Newsletter #11 July 2022

Issue #11, July 2022

Biobridge Foundation, Regenerative Medicine News

Cellular Matrix^® A-CP-HA has been on the market worldwide since 2013. Cellular Matrix® A-CP-HA is a unique technology allowing the preparation, in a one-step procedure and in a close-circuit system, of platelet-rich plasma (PRP) combined with a non-crosslinked hyaluronic acid (HA). Cellular Matrix^® A-CP-HA is a device used to prepare autologous PRP in combination with HA to be used for intra-articular injections into the knee for symptomatic treatment of articular pain and mobility improvement and intra-dermal injections for hydration of dehydrated and wrinkled skin tissues.

At the recent European Alliance of Associations for Rheumatology Congress (EULAR22, June 1-4), the results of a clinical trial comparing Cellular Matrix® A-CP-HA to a hyaluronic acid (Hylan G-F 20, Synvisc-One^®) were presented. The originality of this work lies in the fact that it is the first study comparing Cellular Matrix^® A-CP-HA used in a single injection to the reference hyaluronic acid also used in single injection in mild to moderate knee osteoarthritis.

2 months earlier, following the annual ESSKA congress (20th ESSKA Congress, April 27-29), has been published a consensus document (ORthoBiologic InitiaTive, ORBIT) stating 28 recommendations on the use of PRP in the management of knee osteoarthritis.

This newsletter contains recent publications and information on research and treatments using PRP or BMC concentrate.

Bruno BOEZENNEC, MD, Managing Editor

Latest publication: Randomized clinical trial (RCT), Knee osteoarthritis

Efficacy and safety of the combination of PRP + non-crosslinked hyaluronic acid versus hyaluronic acid, in mono-injection, in symptomatic knee osteoarthritis, randomized controlled phase III trial, single blind.

The purpose of this randomized, controlled, multicenter, non-inferiority clinical trial was to compare the efficacy and safety of the combination of PRP and non-crosslinked hyaluronic acid (Cellular Matrix^® A-CP-HA, Regen Lab, Switzerland,) as a single injection versus Hylan G-F 20 (HA), with follow-up at 1, 3 and 6 months, in knee osteoarthritis.

156 patients [ 40-80 years old with symptomatic femorotibial KOA [ WOMAC A1 (pain on walking) or WOMAC Function > 50/100 and a Kellgren and Lawrence radiographic stage II or III ] were randomized into two groups: Cellular Matrix^® A-CP-HA or HA. The primary endpoint was the difference in the WOMAC score for pain on walking between M0 and M6 between the 2 groups. Secondary endpoints were collected and compared at M1, M3, and M6 (WOMAC Pain, Function, and Total; SF-36 score) as well as the percentage of patients responding at M6 according to the OMERACT-OARSI criteria [ Patient Acceptable Symptomatic State (PASS), and the Minimal Clinical Important Improvement (MCII) of the WOMAC pain ].

The symptomatic improvement (WOMAC pain, function and WOMAC Total) was significant in both groups at M1, M3 and M6 compared to M0. The difference in WOMAC A between M0 and M6 was significant for the non-inferiority test (-6.34 [-12.51; -0.18], p=0.044) and for the superiority test (-6.34 [-12.45; -0.22], p=0.042) in favor of Cellular Matrix^® A-CP-HA. At M6, there was a non-significant difference in terms of OMERACT-OARSI responders in favor of the PRP-HA combination (58% vs. 48%, p=0.261) but significant in terms of MCII responders (78.8% vs. 61.3%, p=0.036) and PASS responders (50.6% vs. 33.3%, p=0.035). There was no difference in patient satisfaction score at M1, M3 and M6, nor in the occurrence of adverse events.

The authors concluded that in this non-inferiority RCT in symptomatic knee osteoarthritis, Cellular Matrix^® A-CP-HA in mono-injection was at least equivalent to Hylan G-F 20 for symptomatic benefit (WOMAC) at 6 months, with a good safety profile. The proportion of patients achieving PASS and MCII of WOMAC pain was higher in the Cellular Matrix^® A-CP-HA group.

Abstract POS1117: https://track.biobridge-event.com/e/915601/mdis-81-Suppl-1-886-2-full-pdf/hp4sw/136381790?h=IKnzh49Li_LuWDdwNyeuyM8j-ipz1RWdpCWKdpkIvtE

RegenLab^® is a leading innovator of medical devices for the preparation of platelet rich plasma (PRP). RegenLab develops, provides expertly designed and patented medical devices for PRP preparations, CE certified by European Notify body, approved by most national agencies worldwide.

The ESSKA ORBIT Consensus

This is a consensus paper which was obtained after more than 2 years of deliberations on the subject, answering 28 specific questions for which an exhaustive review of the literature was conducted and noted by the steering group of 12 experts from 9 different countries. Literature ranging from Grade A (high level of evidence) to Grade D (Expert opinions) were considered.

Clinical evidence confirms the efficacy of PRP in the treatment of KOA). Level I and II clinical studies, as well as additional prospective studies, support the safety and clinical benefit of PRP for knee osteoarthritis (OA), which was shown in comparison to both placebo (saline) and control treatments such as hyaluronic acid or corticosteroids. The efficacy of PRP in the treatment of knee OA has been also supported by meta-analyses and confirms the findings of preclinical research. The consensus group can therefore conclude that there is enough preclinical and clinical evidence to recommend/support the use of PRP in knee OA (Grade A).

More info about ESSKA ORBIT Consensus:
https://track.biobridge-event.com/e/915601/2203-orbit-brochure-spread-pdf/hp4t6/136381790?h=IKnzh49Li_LuWDdwNyeuyM8j-ipz1RWdpCWKdpkIvtE

https://track.biobridge-event.com/e/915601/bit-consensus-complete2022-pdf/hp4t9/136381790?h=IKnzh49Li_LuWDdwNyeuyM8j-ipz1RWdpCWKdpkIvtE

More info about Regen Lab medical devices

These 3 books are intended for physicians who practice and conduct research in disciplines where PRP represents a therapeutic option as well as anyone seeking reliable and up-to-date information on this technology.

Platelet-Rich Plasma (PRP) Standardization & Cell TherapyThis book (178 pages, English) was written to help professionals involved in regenerative medicine to better understand PRP and cell therapies use. Order it Standardized Platelet-Rich Plasma for Musculoskeletal Disorders Based on 20 years of experience, this book (179 pages, English) was written to help professionals involved in the management of patients suffering from musculoskeletal disorders to better understand PRP and its combination with hyaluronic acid. Order it

RegenPRP®: Standardized Platelet Rich Plasma for Skin, Hair & Genitourinary Disorders Based on 20 years of experience, this book (211 pages, English) was written to help professionals involved in regenerative medicine for management of patients suffering from skin, hair and genitourinary disorders to better understand the use of PRP. Order it

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