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Here's a great overview/review lecture on advanced topics in our field.
Adding Regenerative medicine to your practice.
- Thread starter bronchospasm
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You trust that guy with his Japanese whiskey lobster eating grin?
I do.
I do.
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Which kits do you use?
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Would mind sharing the no kit PRP processing?
Just went to the ARMI Regen course (and met oreoandsnake!). Trying to figure out if I should go the kit way or an alternative. Kits seem like they give the most consistent PRP with high platelet counts / dose.
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I've been saying this for years...
Arthroscopy. 2023 Mar 11;S0749-8063(23)00220-7. doi: 10.1016/j.arthro.2023.03.001. Online ahead of print.
Patients With Knee Osteoarthritis Who Receive Platelet-Rich Plasma or Bone-Marrow Aspirate Concentrate Injections Have Better Outcomes Than Patients Who Receive Hyaluronic Acid: Systematic Review and Meta-analysis
John W Belk 1, Joseph J Lim 2, Carson Keeter 3, Patrick C McCulloch 4, Darby A Houck 1, Eric C McCarty 3, Rachel M Frank 3, Matthew J Kraeutler 5
Affiliations expand
PMID: 36913992 DOI: 10.1016/j.arthro.2023.03.001
Abstract
Purpose: To systematically review the literature in order to compare the efficacy and safety of platelet-rich plasma (PRP), bone marrow aspirate concentrate (BMAC), and hyaluronic acid (HA) injections for the treatment of knee osteoarthritis (OA).
Methods: A systematic review was performed by searching PubMed, the Cochrane Library, and Embase to identify Level I studies that compared the clinical efficacy of at least 2 of the following 3 injection therapies: PRP, BMAC, and HA for knee OA. The search phrase used was knee AND osteoarthritis AND randomized AND ("platelet rich plasma" OR "bone marrow aspirate" OR "hyaluronic acid"). Patients were primarily assessed based on patient-reported outcome scores (PROs) including the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), visual analog scale (VAS) for pain, and Subjective International Knee Documentation Committee (IKDC) score.
Results: Twenty-seven studies (all Level I) met inclusion criteria, including 1,042 patients undergoing intra-articular injection(s) with PRP (mean age 57.7 years, mean follow-up 13.5 months), 226 patients with BMAC (mean age 57.0 years, mean follow-up 17.5 months), and 1,128 patients with HA (mean age 59.0 years, mean follow-up 14.4 months). Non-network meta-analyses demonstrated significantly better post-injection WOMAC (p < 0.001), VAS (p < 0.01), and Subjective IKDC scores (p < 0.001) in PRP patients when compared to HA patients. Similarly, network meta-analyses demonstrated significantly better post-injection WOMAC (p < 0.001), VAS (p = 0.03), and Subjective IKDC (p < 0.001) scores in BMAC patients when compared to HA patients. There were no significant differences in post-injection outcome scores when comparing PRP to BMAC.
Conclusion: Patients undergoing treatment for knee OA with PRP or BMAC can be expected to experience improved clinical outcomes when compared to HA patients.
Level of evidence: I, Meta-Analysis of Level I studies.
Copyright © 2023. Published by Elsevier Inc.
Arthroscopy. 2023 Mar 11;S0749-8063(23)00220-7. doi: 10.1016/j.arthro.2023.03.001. Online ahead of print.
Patients With Knee Osteoarthritis Who Receive Platelet-Rich Plasma or Bone-Marrow Aspirate Concentrate Injections Have Better Outcomes Than Patients Who Receive Hyaluronic Acid: Systematic Review and Meta-analysis
John W Belk 1, Joseph J Lim 2, Carson Keeter 3, Patrick C McCulloch 4, Darby A Houck 1, Eric C McCarty 3, Rachel M Frank 3, Matthew J Kraeutler 5
Affiliations expand
PMID: 36913992 DOI: 10.1016/j.arthro.2023.03.001
Abstract
Purpose: To systematically review the literature in order to compare the efficacy and safety of platelet-rich plasma (PRP), bone marrow aspirate concentrate (BMAC), and hyaluronic acid (HA) injections for the treatment of knee osteoarthritis (OA).
Methods: A systematic review was performed by searching PubMed, the Cochrane Library, and Embase to identify Level I studies that compared the clinical efficacy of at least 2 of the following 3 injection therapies: PRP, BMAC, and HA for knee OA. The search phrase used was knee AND osteoarthritis AND randomized AND ("platelet rich plasma" OR "bone marrow aspirate" OR "hyaluronic acid"). Patients were primarily assessed based on patient-reported outcome scores (PROs) including the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), visual analog scale (VAS) for pain, and Subjective International Knee Documentation Committee (IKDC) score.
Results: Twenty-seven studies (all Level I) met inclusion criteria, including 1,042 patients undergoing intra-articular injection(s) with PRP (mean age 57.7 years, mean follow-up 13.5 months), 226 patients with BMAC (mean age 57.0 years, mean follow-up 17.5 months), and 1,128 patients with HA (mean age 59.0 years, mean follow-up 14.4 months). Non-network meta-analyses demonstrated significantly better post-injection WOMAC (p < 0.001), VAS (p < 0.01), and Subjective IKDC scores (p < 0.001) in PRP patients when compared to HA patients. Similarly, network meta-analyses demonstrated significantly better post-injection WOMAC (p < 0.001), VAS (p = 0.03), and Subjective IKDC (p < 0.001) scores in BMAC patients when compared to HA patients. There were no significant differences in post-injection outcome scores when comparing PRP to BMAC.
Conclusion: Patients undergoing treatment for knee OA with PRP or BMAC can be expected to experience improved clinical outcomes when compared to HA patients.
Level of evidence: I, Meta-Analysis of Level I studies.
Copyright © 2023. Published by Elsevier Inc.
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Guaranteed cherry picked literature to review for preselected outcomes.
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...because a bunch of arthroscopic surgeons want to see this technology succeed!
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metaanalysis is always dependent on the data inputted.
it is also dependent on the perspective of the researchers, and it must be noted that these specific researchers went in to the study to prove that PRP and BMAC are better, not to prove a null hypothesis that PRP doesnt help.
also, there is definitely a lot of noise out there. their search revealed 1216 "studies"... and they ended up with only 27.
it is also dependent on the perspective of the researchers, and it must be noted that these specific researchers went in to the study to prove that PRP and BMAC are better, not to prove a null hypothesis that PRP doesnt help.
so this does show a degree of predetermination which, in my mind at least, tends to downgrade what they found (because they found what they wanted to see).
also, there is definitely a lot of noise out there. their search revealed 1216 "studies"... and they ended up with only 27.
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Link
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Video Conferencing, Web Conferencing, Webinars, Screen Sharing
Zoom is the leader in modern enterprise video communications, with an easy, reliable cloud platform for video and audio conferencing, chat, and webinars across mobile, desktop, and room systems. Zoom Rooms is the original software-based conference room solution used around the world in board...
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If someone injected my thumb with steroids, I'd be pissed...
Plast Reconstr Surg. 2023 Apr 11.
doi: 10.1097/PRS.0000000000010516. Online ahead of print.
Affiliations expand
Patients and methods: A blinded, randomized controlled trial was conducted. 95 patients with CMC1 arthritis were included in the study. The mean follow-up period was 2 years. Participants were injected with 1.5ml of autologous fat, PRP, autologous fat and PRP, or saline solution 0.9% into the CMC1 joint depending on the group allocation.The primary outcome of this study was the evaluation of pain reduction in each treatment group.
Results: The combination of fat and PRP was the only treatment that resulted in a significantly greater reduction in pain compared to 0.9% saline (p=0.003). Similarly, fat and PRP in combination was the only therapy group to achieve clinically relevant quick disabilities of arm, shoulder, and hand (Dash) score reduction, and the only group that showed a significantly better Short Form (SF)-36 score than 0.9% saline (p=0.016). No major complications were noted.
Conclusion: In addition to pain reduction, the combination of autologous fat and PRP yields a relevant improvement in hand function and a corresponding improvement in quality of life, and seems to be a viable and safe alternative to short-acting glucocorticoids.
Copyright © 2023 by the American Society of Plastic Surgeons.
Plast Reconstr Surg. 2023 Apr 11.
doi: 10.1097/PRS.0000000000010516. Online ahead of print.
Minimal invasive treatment of trapeziometacarpal osteoarthritis: Results of a blinded, randomized controlled trial
Raimund Winter 1, Alexandru-Cristian Tuca 1, Ivo Justich 1, Sebastian Tschauner 2, Herwig Friedl 3, Werner Girsch 1, Patricia Lebo 1, Robert Zrim 1, David Benjamin Lumenta 1, Lars-P Kamolz 1 4Affiliations expand
- PMID: 37039525
- DOI: 10.1097/PRS.0000000000010516
Abstract
Background: Surgical therapy for widespread CMC1 arthritis permanently alters the physiological anatomy of the hand. The injection of autologous substances into the thumb saddle joint could achieve temporary pain relief and delay surgical indications.This trial aimed to compare the pain-reducing effects of autologous fat and/or platelet-rich plasma (PRP) with saline 0.9% in the infiltration therapy of carpometacarpal arthritis of the thumb (CMC1 arthritis).Patients and methods: A blinded, randomized controlled trial was conducted. 95 patients with CMC1 arthritis were included in the study. The mean follow-up period was 2 years. Participants were injected with 1.5ml of autologous fat, PRP, autologous fat and PRP, or saline solution 0.9% into the CMC1 joint depending on the group allocation.The primary outcome of this study was the evaluation of pain reduction in each treatment group.
Results: The combination of fat and PRP was the only treatment that resulted in a significantly greater reduction in pain compared to 0.9% saline (p=0.003). Similarly, fat and PRP in combination was the only therapy group to achieve clinically relevant quick disabilities of arm, shoulder, and hand (Dash) score reduction, and the only group that showed a significantly better Short Form (SF)-36 score than 0.9% saline (p=0.016). No major complications were noted.
Conclusion: In addition to pain reduction, the combination of autologous fat and PRP yields a relevant improvement in hand function and a corresponding improvement in quality of life, and seems to be a viable and safe alternative to short-acting glucocorticoids.
Copyright © 2023 by the American Society of Plastic Surgeons.
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Participants were injected with 1.5ml of autologous fat, PRP, autologous fat and PRP, or saline solution 0.9% into the CMC1 joint depending on the group allocation.
You mean you would be pissed if they did not include a steroid arm in their study?
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That wouldn't get past IRB. "First, do no harm." We've known for a long time that steroids are no bueno for joints. But, if you're just Government cheese for "insurance" you don't have many other good options.
Knee Surg Sports Traumatol Arthrosc. 2012 Sep;20(9):1809-14. doi: 10.1007/s00167-011-1820-6. Epub 2011 Dec 21.
The chondrotoxicity of single-dose corticosteroids
Jason L Dragoo 1, Christina M Danial, Hillary J Braun, Michael A Pouliot, Hyeon Joo Kim
Affiliations expand
PMID: 22186921 DOI: 10.1007/s00167-011-1820-6
Abstract
Purpose: Corticosteroids are commonly injected into the joint space. However, studies have not examined the chondrotoxicity of one-time injection doses. The purpose of this study is to evaluate the effect of dexamethasone sodium phosphate (Decadron), methylprednisolone acetate (Depo-Medrol), betamethasone sodium phosphate and betamethasone acetate (Celestone Soluspan), and triamcinolone acetonide (Kenalog) on human chondrocyte viability in vitro.
Methods: Single-injection doses of each of the corticosteroids were separately delivered to human chondrocytes for their respective average duration of action and compared to controls using a bioreactor containing a continuous infusion pump constructed to mimic joint fluid metabolism. A 14-day time-controlled trial was also performed. A live/dead reduced biohazard viability/cytotoxicity assay was used to quantify chondrocyte viability.
Results: Over their average duration of action, betamethasone sodium phosphate/acetate solution and triamcinolone acetonide caused significant decreases in chondrocyte viability compared to control media (19.8 ± 2.9% vs. 5.2 ± 2.1%, P = 0.0025 and 10.2 ± 1.3% vs. 4.8 ± 0.9%, P = 0.0049, respectively). In the 14-day trial, only betamethasone sodium phosphate/acetate solution caused a significant decrease in chondrocyte viability compared to control media (21.5% vs. 4.6%, P < 0.001).
Conclusions: A single-injection dose of betamethasone sodium phosphate and betamethasone acetate solution illustrated consistent and significant chondrotoxicity using a physiologically relevant in vitro model and should be used with caution. Given the observed chondrotoxicity of triamcinolone acetonide in a single trial, there may be some evidence that this medication is chondrotoxic. However, at 14 days, betamethasone sodium phosphate and betamethasone acetate was the only condition that caused significant cell death.
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Poor pivot. Current standard of care treatment is IA steroids.
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That ship has sailed. What would a "reasonable" physician knowing all that s/he knows, do in similar circumstances? You can't unknow what I've told you...
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Agree. Tough in my ortho group as they are touchy about getting all the peripheral joint cases. 95% of what I do is spine.
But for the patients who have refused surgery, I can be honest and I give them both options.
A cortisone shot covered by insurance or a cash PRP injection, and I let them know if it was my joint/tendon, I’d do the PRP injection, because that is what I do for myself.
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Reasonable still puts in steroids. Thousands of times per day across the country. PRP is still snake oil until you standardize it and the costs.
Also, local is not chondrotoxic at low anesthetic doses. 1% lido no, 2% lido yes. 0.25% bupi no, 0.5% bupi yes.
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and how do you phrase this without the obvious bias that you get paid handsomely for the PRP injection?
there is an inherent conflict of interest since one is cash and the other is through their insurance. hence the importance of getting PRP covered by insurance.
OTOH, as drusso has noted, once PRP is covered by insurance, then the value of PRP for any private practice drops considerably.
=== regarding the study...
1. their conclusions do not fit with their study.
they are reaching a little in coming to that conclusion, since they did not compare their treatments directly to gluocorticoids.
2. it should be aconcern you that the PRP and the fat group did not have benefit over saline.
the explanation was not based on this study, but it was explained on the statement "other studies say the PRP should be done more than once for benefit".
3. it was a single blinded study. there is some inherent bias.
the proceduralists knew what they were injecting and were not blinded because they would be able to tell based on tactile feel of the syringe.
they said this was impossible to avoid. but a simple solution would be to have the proceduralist place the needle attached to an opaque extension tube and have an assistant inject.
4. clinically, noone really improved that much.
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How do you ignore the fact that your employer gets paid handsomely for what you do?
No one disputes that PRP is bioactive anymore. Everyone agrees on the MOA of platelets. No one thinks that the proceduralist's INTENTION to heal the patient actually causes the platelets to work better. No one thinks that Regen works because of psychokinesis.
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I believe part of PRP success is psychokinesis. Or rather, the physicians positive showing of belief that the treatment will be beneficial incudes a placebo benefit.
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if it is standard of care, please post the Medicare guidelines regarding PRP.
not to say that Medicare is the right way to do things - but it is the defacto standard of care.
now i would not mind if Medicare allowed PRP for tendonitis, or frozen shoulder, or epicondylitis, or even osteoarthritis of knees...
if you are so sure that PRP is standard of care, however, you might want to rethink your position on it being offered through Medicare (in a previous post, i believe you did not want Medicare to approve PRP).
not to say that Medicare is the right way to do things - but it is the defacto standard of care.
now i would not mind if Medicare allowed PRP for tendonitis, or frozen shoulder, or epicondylitis, or even osteoarthritis of knees...
if you are so sure that PRP is standard of care, however, you might want to rethink your position on it being offered through Medicare (in a previous post, i believe you did not want Medicare to approve PRP).
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As a Libertarian, I think the government is terrible at just about everything, and I could care less what government bureaucrats think about PRP!
I know that PRP works. It has worked magic on countless patients who failed steroid injections. Including twice on me.
I had 3 days of relief after both a knee and an ankle injection with steroid. Repeated with PRP and both PRP injections gave me approx 75% relief for over a year compared to just 3 days after steroids. I see the same thing in patients every month.
Only liberals/democrats think that a government guideline should direct the actions of a board certified physician, who have far greater understanding of medicine than bureaucrats.
Independents/libertarians do not believe that "government knows best".
I also believe in speeding when the conditions allow for it...........
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You are experiencing bias with your relief. It is why better literature needs to be done. Like the last study that drusso posted: pure crap and only published to validate preconceived notions of the expected outcomes.
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100% agree that more good studies need to be done on PRP
Please read my post again. I wasn't just referring to me. I have had over a hundred total patients, who failed steroid injections at various locations but obtained good relief from PRP.
I prefer to give patients hope, and not just tell them that their only options are to just suffer or to take life long medications, as some doctors do.
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Standard of care is determined by experts, not the Government.
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Look: This has been investigated, and the effect size is tiny...You are not Eleven from Stranger Things. Your belief in the therapy will not materially impact the outcome, the rate at which platelets degranulate, the concentration of the platelets, etc, but certainly your bad attitude could sabotage any doctor-patient relationship.
PRP works despite the doctor having good or bad thoughts about the treatment. I showed, that at least for manual therapies, it doesn't even matter if the patient believes it works. It doesn't materially affect outcomes even if they *SUSPECT* which group they're in. Apparently, when it comes to being a research subject the standard is not complete concealment but rather "reasonable doubt" about which group you've been assigned.
@Ducttape and other skeptics insist that extraordinary resources be put into Regen Med research to control such a tiny contribution to the therapy's treatment effect. All this does is reduce access and impede the development of the field. Studies also show that chemotherapy for cancer "works better" if the oncologist giving it is not a @sswhole. Does that mean we need separate arms of chemo studies where patients are assigned to mean and nice oncologists?
J Altern Complement Med. 2004 Jun;10(3):438-48.
doi: 10.1089/1075553041323803.
A randomized trial of the effects of remote intercessory prayer: interactions with personal beliefs on problem-specific outcomes and functional status
Raymond F Palmer 1, David Katerndahl, Jayne Morgan-KiddAffiliations expand
- PMID: 15253847
- DOI: 10.1089/1075553041323803
Abstract
Objectives: Investigate the relevance of interpersonal belief factors as modifiers of the effectiveness of intercessory prayer.Design: Randomized clinical trial.
Setting/location: Community-dwelling adults recruited from seven local church groups.
Subjects: Eighty-six (86) male and female participants 18-88 years of age were randomly assigned to either treatment (n = 45) or control groups (n = 41).
Interventions: Several volunteers committed to daily prayer for participants in the intervention group. Intercessory prayer commenced for 1 month and were directed toward a life concern or problem disclosed by the participant at baseline. Participants were unaware of being prayed for.
Outcomes measures: Degree to which their problem had been resolved and the current level of concern they had about a specific life problem they described at baseline. Four component scores from the Medical Outcomes Study SF-20 were also used.
Results: No direct intervention effect on the primary outcomes was found. A marginally significant reduction in the amount of pain was observed in the intervention group compared to controls. The amount of concern for baseline problems at follow-up was significantly lower in the intervention group when stratified by subject's baseline degree of belief that their problem could be resolved. Prayer intervention appeared to effectively reduce the subject's level of concern only if the subject initially believed that the problem could be resolved. Those in the intervention group who did not believe in a possible resolution to their problem did not differ from controls. Better physical functioning was observed in the intervention group among those with a higher belief in prayer and surprisingly, better mental health scores were observed in the control group with lower belief in prayer scores.
Conclusions: The results of the current study underscore the role of interpersonal belief in prayer efficacy and are consistent with the literature showing the relevance of belief in health and well-being in general. The relevance of interpersonal belief factors of the participants is recommended in future investigations.
J Am Osteopath Assoc. 2006 Aug;106(8):457-63.
Blinding protocols, treatment credibility, and expectancy: methodologic issues in clinical trials of osteopathic manipulative treatment
John C Licciardone 1, David P Russo
Affiliations expand
PMID: 16943515
Abstract
Context: In testing an experimental new drug or therapy, the gold standard in biomedical research for determining treatment efficacy is the randomized controlled trial (RCT). In pharmaceutical trials, inert placebos are an easily administered control that facilitates blinded comparisons. In clinical trials that study the effects of manual interventions, researchers must carefully consider their use of treatment control models. Choosing credible controls that will minimize bias in osteopathic manipulative treatment (OMT) clinical trials poses unique challenges to researchers because of heterogeneous OMT methods and practice.
Objective: To compare the treatment credibility of sham manipulative treatment and untreated controls to active OMT.
Methods: Subjects recruited for an OMT clinical trial for chronic low back pain completed a treatment-credibility rating scale comparing two written descriptions of the study interventions offered. The scale was administered to subjects before trial entry and at 6-month follow-up. Scale scores were used to compute credibility ratios for both intervention protocols (ie, OMT vs sham manipulative treatment). Repeated measures analysis of variance was used to assess changes in the credibility ratio over time, including the measurement of study group and time main effects, as well as study group x time interaction effects.
Results: Subjects (N=91) perceived OMT as a more credible therapeutic option than sham manipulative treatment both at trial entry and at 6-month follow-up (P<.05). Among subjects completing the study protocol (n=66), there were no changes in the perceived credibility of the study interventions over time. There were no significant differences in the credibility ratio among study groups (P=.64) or over time (P=.79). In addition, there were no significant study group x time interactions (P=.59).
Conclusions: In clinical trials, subjects may perceive OMT as a more credible treatment alternative than many control procedures. Treatment credibility can interact with subject expectations and study design in complex ways. When analyzing the treatment effects of OMT, investigators must consider the effects of these two subjective elements when competing interventions are offered and subjects are asked to self-report data. Study design should be optimized to equalize these effects among interventions.
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Snake oil salesman. You should have stuck with OMM.
Nik would talk to me about the music in the procedure suite might make all the difference in the outcomes based on the literature w have.
We have not improved the quality of the literature and you are proving that.
Nik would talk to me about the music in the procedure suite might make all the difference in the outcomes based on the literature w have.
We have not improved the quality of the literature and you are proving that.
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GIGO: They didn’t ensure the control group was blocked from receiving remote intercessory prayer.
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More evidence for the psychokinetic, intercessory prayer effects of platelet-derived growth factors...
Int Wound J. 2023 May 4. doi: 10.1111/iwj.14186. Online ahead of print.
Perilesional injections of human platelet lysate versus platelet poor plasma for the treatment of diabetic foot ulcers: A double-blinded prospective clinical trial
Hussam Alhawari 1, Hanan Jafar 2 3, Mohammad Al Soudi 4, Lena Abu Ameereh 2, Maram Fawaris 2, Mohanad Saleh 2, Safwan Aladwan 5, Nidal Younes 6, Abdalla Awidi 2 7 8
Affiliations expand
PMID: 37140065 DOI: 10.1111/iwj.14186
Abstract
Diabetic foot ulcer (DFU) is a major cause of morbidity, non-traumatic lower limb amputation in diabetic patients and a high-cost burden on the healthcare system. New therapeutic products are increasingly tested. Platelet-rich plasma (PRP) and human platelet lysate (hPL) are reported to be useful. This trial was conducted to test whether the healing effect of hPL in chronic DFU was due to plasma or platelet lysates in a prospective double-blind design.
Autologous PRP was obtained from citrated blood, lysed, and used as drug 1 (active product). The platelet-poor plasma (PPP) was used as a drug 2 (placebo). Ten patients were enrolled in arm 1 and 9 in arm 2. The drugs were injected perilesionally every two weeks for a total of six injections. Adverse events were recorded until Week 14. The DFUs were scored per the Texas and Wegner systems. No patient showed any major adverse events.
Some reported local pain post-injection. Wound healing was achieved in the hPL group in 9/10 of patients at a mean of 35.1 days. In the PPP group, no patient had healed by Day 84. The difference was statistically significant at P < 0.00001.
We conclude that autologous hPL is safe and highly effective in healing chronic DFU and is superior to autologous PPP.
Keywords: diabetes; foot ulcers; platelet lysate; regenerative medicine; wound healing.
Int Wound J. 2023 May 4. doi: 10.1111/iwj.14186. Online ahead of print.
Perilesional injections of human platelet lysate versus platelet poor plasma for the treatment of diabetic foot ulcers: A double-blinded prospective clinical trial
Hussam Alhawari 1, Hanan Jafar 2 3, Mohammad Al Soudi 4, Lena Abu Ameereh 2, Maram Fawaris 2, Mohanad Saleh 2, Safwan Aladwan 5, Nidal Younes 6, Abdalla Awidi 2 7 8
Affiliations expand
PMID: 37140065 DOI: 10.1111/iwj.14186
Abstract
Diabetic foot ulcer (DFU) is a major cause of morbidity, non-traumatic lower limb amputation in diabetic patients and a high-cost burden on the healthcare system. New therapeutic products are increasingly tested. Platelet-rich plasma (PRP) and human platelet lysate (hPL) are reported to be useful. This trial was conducted to test whether the healing effect of hPL in chronic DFU was due to plasma or platelet lysates in a prospective double-blind design.
Autologous PRP was obtained from citrated blood, lysed, and used as drug 1 (active product). The platelet-poor plasma (PPP) was used as a drug 2 (placebo). Ten patients were enrolled in arm 1 and 9 in arm 2. The drugs were injected perilesionally every two weeks for a total of six injections. Adverse events were recorded until Week 14. The DFUs were scored per the Texas and Wegner systems. No patient showed any major adverse events.
Some reported local pain post-injection. Wound healing was achieved in the hPL group in 9/10 of patients at a mean of 35.1 days. In the PPP group, no patient had healed by Day 84. The difference was statistically significant at P < 0.00001.
We conclude that autologous hPL is safe and highly effective in healing chronic DFU and is superior to autologous PPP.
Keywords: diabetes; foot ulcers; platelet lysate; regenerative medicine; wound healing.
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You only post this because it’s another stupid study. Has anyone considered platelet poor plasma a reasonable injection for wound healing? How long does it take Wounds to heal with doing nothing? What is the standard of care treatment? This is a useless study.
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Platelet-poor plasma is the perfect comparator because only YOU believe platelets work by magic.
The rest of the scientific community accepts the fact that platelets are bioactive substances that affect tissue healing. PPP contains cytokines that affect tissue healing too but contains no platelets. PRP contains both cytokines AND platelets.
The Effects of Platelet-Rich and Platelet-Poor Plasma on Biological Characteristics of BM-MSCs In Vitro
Platelet-rich plasma (PRP) and its byproduct platelet-poor plasma (PPP) are rich sources of cytokines in tissue damage repair. Bone marrow-derived mesenchymal stem cells (BM-MSCs) have received more and more attention for their ability to treat multiple ...
www.ncbi.nlm.nih.gov
The biological effects of PPP are to participate in hemostasis and coagulation, to act as a cell attachment vector, and also to promote mitosis of fibroblasts and epithelial cells [8]. Although PPP is not as concentrated in platelets as PRP, it has been demonstrated that PPP can sustain cell growth and survival as well. PPP promotes wound healing-associated cell functions and accelerates cell migration and proliferation of fibroblasts [9–11].
Map out the deductive logic on a whiteboard, and it makes sense...
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It would only make sense if PPP was usual care. It is not. Comparing tangerines to bicycles.Platelet-poor plasma is the perfect comparator because only YOU believe platelets work by magic.
The rest of the scientific community accepts the fact that platelets are bioactive substances that affect tissue healing. PPP contains cytokines that affect tissue healing too but contains no platelets. PRP contains both cytokines AND platelets.
The Effects of Platelet-Rich and Platelet-Poor Plasma on Biological Characteristics of BM-MSCs In Vitro
Platelet-rich plasma (PRP) and its byproduct platelet-poor plasma (PPP) are rich sources of cytokines in tissue damage repair. Bone marrow-derived mesenchymal stem cells (BM-MSCs) have received more and more attention for their ability to treat multiple ...
The biological effects of PPP are to participate in hemostasis and coagulation, to act as a cell attachment vector, and also to promote mitosis of fibroblasts and epithelial cells [8]. Although PPP is not as concentrated in platelets as PRP, it has been demonstrated that PPP can sustain cell growth and survival as well. PPP promotes wound healing-associated cell functions and accelerates cell migration and proliferation of fibroblasts [9–11].
Map out the deductive logic on a whiteboard, and it makes sense...
Needed suspected treatment A, usual care, and do nothing arms to plan a trial.
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the claims made by the study far outreach what was actually studied.
1. it wasnt blinded. that can add bias, and could lead to subtle changes of technique that could influence the results.
2. small study size, although it might have been powered enough due to the difference in results
3. most importantly, they claim that PPP is placebo but what if there are factors in the PPP that actively promote lack of healing?
which, in fact, makes me wonder if this is why PRP doesnt work for some people - the quality of the PRP and/or how one obtains the PRP may influence the substance injected and confound results.
of note, inclusion criteria did weed out a lot of preexisting conditions -
1. it wasnt blinded. that can add bias, and could lead to subtle changes of technique that could influence the results.
2. small study size, although it might have been powered enough due to the difference in results
3. most importantly, they claim that PPP is placebo but what if there are factors in the PPP that actively promote lack of healing?
which, in fact, makes me wonder if this is why PRP doesnt work for some people - the quality of the PRP and/or how one obtains the PRP may influence the substance injected and confound results.
of note, inclusion criteria did weed out a lot of preexisting conditions -
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Yeah, you're studying tangerines in a study about making punch. Why are you a platelet bioactivity denier?
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The blinding is only required if you think platelets are sentient or magic. Have you ever tried to fool or influence a platelet? They are very stoic and stubborn.
The host factors you outline above is EXACTLY why PRP doesn't "work" for everyone. It's not an FDA-approved drug. It's your own autologous tissue. It's the same reason why there are not FDA-approved surgeries and surgery doesn't "work" for everyone.
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the blinding is required if you want to prove that it works beyond standard of care. PRP and PPP are not standard of care. suppose 100% of diabetic ulcers healed without any injection, PRP or PPP. they did 2 interventions, so they really should be only able to compare between the 2.
your last comment is telling - PRP is only going to work for certain people.
or maybe it is placebo, because placebo works for certain people.
yet because of this, certain people in which it would work for are denied that treatment purely for financial reasons.
your last comment is telling - PRP is only going to work for certain people.
or maybe it is placebo, because placebo works for certain people.
yet because of this, certain people in which it would work for are denied that treatment purely for financial reasons.
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No, no, no.
Placebos are not required for non-inferiority/superiority trials of a standard of care. Standard of care is the required comparator. There are hundreds of studies comparing PRP to steroids, PRP to dry-needling prolotherapy/dextrose, PRP to surgery, PRP to positive thinking, etc.
Placebos are required to control for the effects of magical thinking, intercessory prayer, and psychokinesis. If you believe that platelets are magical substances with magical powers, then you need a magical comparator to control for the possible magical treatment effect they exert. Placebos are the perfect magical comparators because they are biologically inert but produce magical effects.
If you believe that platelets are real bioactive substances that contain cytokines and other chemicals that are involved in the inflammatory cascade, chemotaxis, and tissue repair, then you need a comparator that controls for that. PPP is a good one.
Name one medical or surgical treatment not impacted by the patient's health status.
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you are presuming that PPP is biologically inert. i would argue that PPP is not. articles suggest that it is not thought to be inert.
what studies do you have that show that PPP is inert? a further question i have now is whether there may be negative factors from PPP, that could be "balanced" out by the platelets themselves.
but, for sake of being argumentative:
laceration repair.
cerumen debridement.
nonoperative shoulder reduction.
splinting extremity injury
what studies do you have that show that PPP is inert? a further question i have now is whether there may be negative factors from PPP, that could be "balanced" out by the platelets themselves.
loaded question - the fact that you are doing a treatment suggests that there is a change in patient health status.
but, for sake of being argumentative:
laceration repair.
cerumen debridement.
nonoperative shoulder reduction.
splinting extremity injury
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PPP is not inert. It contains the same serum growth factors as PRP without platelets. PPP controls for platelets. Platelets are the presumed active ingredient. It's the only thing that is different between PRP and PPP.
I'm saying that patient health status, or host factors, is a known confounder for orthobiologics because orthobiologics are not standardized FDA-approved drugs. Orthobiologics are autologous tissue products.
What's a placebo for a laceration repair?
What's a placebo for cerumen debridement? How would you prove cerumen debridement "works?"
What's a placebo for a nonoperative shoulder reduction? How about we just pretend to reduce it and send the patient home? Sham reduction.
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so you are confirming that they tested a biologically active substance to another biologically active substance.
this was their hypothesis:
their conclusion was much broader.
curious - has anyone studied injecting donor platelets without plasma?
===
you asked a specific question about circumstances in which the patients health has little impact on treatment.
i gave you some examples. stop moving the goalposts.
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Randomized Controlled Trial
Regen Med. 2021 Feb;16(2):113-115.
doi: 10.2217/rme-2020-0104. Epub 2021 Mar 23.
Using intra-articular allogenic lyophilized growth factors in primary knee osteoarthritis: a randomized pilot study
Rasmia El-Gohary 1, Amany Diab 1, Hala El-Gendy 1, Hossam Fahmy 2, Kamel Heshmat Gado 1Affiliations expand
- PMID: 33754800
- DOI: 10.2217/rme-2020-0104
Abstract
Objective: Investigating the safety in addition to clinical and structural efficacy of allogenic lyophilized growth factors (L-GFs) in patients with symptomatic primary knee osteoarthritis.Design: A prospective, open-label pilot study. A total of 31-patients randomized into non-intervention and intervention groups.
Materials & methods: The intervention group received two intra-articular doses at baseline and after 2-months. Post-injection complications were documented, and the efficacy was assessed by Western Ontario and McMaster Universities Osteoarthritis Index scores and ultrasonography.
Results: One dropout from the intervention group. The percentage of improvement of mean Western Ontario and McMaster Universities Osteoarthritis Index-scores and ultrasonography-detected effusion were statistically significant in the intervention group compared with the non-intervention. A brief, mild, post-injection pain was reported by all intervention group.
Conclusion: This study provides the safety of intra-articular injection of allogenic L-GFs in knee osteoarthritis. The conclusion of efficacy was limited by small sample size and lack of control injection.
Clinical trial registration: NCT04331327 (ClinicalTrials.gov, retrospectively registered).
Keywords: allogenic platelet-rich plasma; growth factors; knee; lyophilization; osteoarthritis.
Med Glas (Zenica). 2021 Feb 1;18(1):260-266.
doi: 10.17392/1330-21.
Allogenic platelet concentrates from umbilical cord blood for knee osteoarthritis: preliminary results
Vincenzo Caiaffa 1, Francesco Ippolito 1, Antonella Abate 1, Vittorio Nappi 1, Michele Santodirocco 2, Domenico Visceglie 3Affiliations expand
- PMID: 33655742
- DOI: 10.17392/1330-21
Abstract
Aim: To investigate the role of cordonal blood platelet-rich plasma (PRP) intra-articular injections for treating the patients with knee osteoarthritis in terms of procedure safety and clinical outcomes.Methods: Twenty-five patients affected by knee osteoarthritis were enrolled and received one single intra-articular knee injection of umbilical cord PRP in a volume of 10 mL. A follow-up was investigated at time 0, 4, 8, 12 weeks and 6 months, evaluating clinical parameters and functional performances.
Results: No serious adverse events were identified. The paired ttest analysis showed a significant difference between baseline and each follow-up times for all clinical scales (p<0.05), with a significant improvement of clinical outcomes. Conclusion Allogeneic PRP can generate reliable therapeutic effect. The high content of tissue regenerative factors in cord blood platelets makes cordonal blood one of the ideal sources of PRP.
Keywords: allogenic; cordonal; osteoarthritis; platelet rich plasma.
Comparative Study
Am J Sports Med.
2018 Nov;46(13):3142-3154.
doi: 10.1177/0363546518800268. Epub 2018 Oct 12.
Allogenic Pure Platelet-Rich Plasma Therapy for Rotator Cuff Disease: A Bench and Bed Study
Chris Hyunchul Jo 1 2, Seung Yeon Lee 1, Kang Sup Yoon 1, Sohee Oh 3, Sue Shin 4Affiliations expand
- PMID: 30311796
- DOI: 10.1177/0363546518800268
Abstract
Background: Although platelet-rich plasma (PRP) is a popular option for rotator cuff disease, the underlying mechanism of PRP and its clinical indications are unclear. Further, some kinds of PRP might be detrimental to patients. Allogenic PRP prepared through a standardized process and fully characterized could eliminate variations in PRP as well as uncertainties regarding its use in each patient, which could provide clues about its mechanism of action and indications for its use.Purpose: To assess the effects of pure PRP on tenocytes with or without inflammation in an in vitro study and to evaluate the safety and efficacy of a fully characterized pure PRP injection in patients with rotator cuff disease in a clinical study.
Study design: Controlled laboratory study and cohort study; Level of evidence, 3.
Methods: For the in vitro study, tenocytes were enzymatically isolated and cultured from patients with rotator cuff tear and treated with or without interleukin 1β (IL-1β) and PRP. Gene expression and protein synthesis of pro- and anti-inflammatory cytokines, enzymes and their inhibitors, matrix synthesis, and cell viability were evaluated. For the clinical study, a total of 17 patients with rotator cuff disease received ultrasonography-guided subacromial PRP injection and were followed for 6 months. Pain, range of motion, muscle strength, shoulder function, and overall satisfaction in patients were compared with the results in a propensity score-matched control group who received corticosteroid (triamcinolone acetonide 40 mg).
Results: PRP induced inflammation in the absence of inflammation and ameliorated inflammation in IL-1β-induced tendinopathic conditions by regulation of cytokines such as IL-1β, cyclooxygenase 2, microsomal prostaglandin E synthase 1, vasoactive intestinal peptide, and downstream matrix metalloproteinases. No general or local adverse events were noted with regard to allogenic PRP injection. Whereas steroid injection showed earlier improvement in some kinds of pain and functional scores, PRP generally showed comparable effects with steroid injection in all clinical outcomes at 6 months.
Conclusion: This study showed that allogenic pure PRP had pleiotropic effects on tenocytes depending on inflammation and that it did not cause adverse events but rather decreased pain and improved shoulder function to a degree comparable with steroid injection in patients with rotator cuff disease.
Clinical relevance: Allogenic PRP could be a treatment option for rotator cuff disease.
Keywords: allogenic platelet-rich plasma; pleiotropic effects; rotator cuff disease; tendinopathy.
He’s still young…..he will figure it out
Dogs, horses, and other animals do not malinger and do not lie about the efficacy of prp.
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so by these studies - Medicare should approve allogenic platelet therapy.
maybe the focus on regenerative therapy should be on developing an easy and cost effective animal model to produce allogenic platelets and PRP for injection to all people with osteoarthritis.
maybe we should remove the focus on it being a money making endeavor, and instead allow all patients with appropriate medical conditions to be able to access such care...
maybe the focus on regenerative therapy should be on developing an easy and cost effective animal model to produce allogenic platelets and PRP for injection to all people with osteoarthritis.
maybe we should remove the focus on it being a money making endeavor, and instead allow all patients with appropriate medical conditions to be able to access such care...
