A Phase 1/2 interventional study of Autologous biologic drug of innovative therapy /cell therapy drug in Knee Osteoarthritis, sponsored by Clinique Juge. Completed at 1 site in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-04-20.
Sponsored by Clinique Juge · Phase 1/2, Interventional, and Treatment
The hypothesis of this project is that the injection of an innovative treatment (microfat and dose of autologous PRP) allows to delay knee arthroplasty in patients with knee OA resistant to medical treatment.
Osteoarthritis is the most common joint disease in the world and one of the most common causes of pain and functional disability. The incidence of cartilage pathology has grown due to the ageing population, and the increase in sports participation and its associated trauma. The treatment of these cartilage damage is limited and remains a major public health issue.
The aim of the medical treatment and intra articular injections consists in reducing pain and improving the knee function in order to limit the sport, professional and social negative impact in the youngest patients. Nevertheless their efficacy remain non predictable in patients.
The arthroplasty will be proposed in the final intention. Insofar arthroplasty is a surgical procedure 1 / which presents a potential infectious risk associated with its invasive nature, 2 / it requires iterative revision surgery, especially in young patients given the limited lifetime of the implants and 3 / whose complete postoperative recovery take several months, it seems justified to continue studies to validate effective alternative treatments to delay the use of joint replacements.
Recently, the emergence of biotherapy in orthopedics has developed the use of intra-articular injections of platelet-rich plasma (PRP). Their use has increased substantially and is based on the demonstration that platelet-rich plasma concentrate growth factors, can stimulate cartilage regeneration in vitro and in vivo preclinical models. In humans, recent data from the literature show that these autologous products are very well tolerated. Their scientific evaluation remains difficult in that 1 / indications and surgical procedures are not harmonized 2 / manufacturing processes PRP are not standardized 3 / quantitative and qualitative composition of PRP is rarely documented.
PRP administration procedures can be optimized: indeed in that, it is a liquid preparation (platelet suspension), its administration in a interface tissue allows to limit its spread and potentiate its trophic effect on the injured cartilage site. Adipose tissue is the most relevant interface tissue given, because it's a tissue rich in stem cells with full therapeutic potential and is easily accessible by subcutaneous minimally invasive procedure. Thus, autologous microfat (fat removed under local anesthesia by manual liposuction using fine cannulas specific) administered in the synovial capsule, could play the matrix to receive the injection of PRP.
The hypothesis of this project is that the standardized injection of an innovative treatment (microfat and dose of autologous PRP) allows to delay knee arthroplasty in patients with knee OA resistant to medical treatment. This treatment, minimally invasive and with economically reasonable cost, would provide a new treatment for second intention. In terms medicoeconomic if this treatment is effective over a period of several years, even in cases where it is necessary to do it one or two times, it would significantly reduce the financial and societal impact of joint replacements.
3,391 studies on the registry are indexed under Osteoarthritis, Knee; 628 are open to participants now.
This study's enrollment of 30 is below the median of 69 across 2,808 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →This is the only study on the registry with Clinique Juge as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
microfat (5 ml) associated with PRP with a dose of 3 billions of platelets (5 ml)
Drug: Autologous biologic drug of innovative therapy /cell therapy drug
microfat (5 ml) associated with PRP with a dose of 1 billion of platelets (5 ml)
Drug: Autologous biologic drug of innovative therapy /cell therapy drug
microfat (5 ml) and saline solution (5 ml)
Drug: Autologous biologic drug of innovative therapy /cell therapy drug
Articular knee injection of microfat associated with a dose of 3 billions of platelets or associated with a dose of 1 billion of platelets or with saline solution
Cartilage relaxation time on MRI T2-mapping at 3 months
The primary objective of this study is to demonstrate the efficacy of intra-articular injection of autologous microfat associated with a standardized preparation of autologous PRP, by changes in the cartilage relaxation time on MRI T2-mapping at 3 months.
Time frame: Baseline and 3 months post injection
Improved of chondral lesion on MRI
Improved chondral lesions at 3 months and 6 months on specific MRI cartilage sequences (DP FATSAT Axial, Axial T1, T2 mapping): quantitative morphological sequences resolution and qualitative structural sequences.
Time frame: Baseline and 3 and 6 months post injection
Pain
The evolution of pain with the visual analogic scale compared to the initial state (scores at baseline) and the evolution of pain (VAS score) at 1, 3 and 6 months post-injection. Scale from 0 (no pain) to 10 (maximal pain)
Time frame: Baseline and 1 and 3 and 6 months post injection
Responding patients
The proportion of patients not responding to treatment.
Time frame: Baseline and 3 and 6 months post injection
Biologic parameters / clinical efficacity
The correlation between clinical efficacy and dose of PRP administered and dose of growth factors administered.
Time frame: Baseline and 3 and 6 months post injection
WOMAC
The evolution of the functional impact of knee osteoarthritis with the Western Ontario and McMaster University Osteoarthritis score at 1, 3 and 6 months post-injection. Score from 0 to 96 (the worst)
Time frame: Baseline and 1 and 3 and 6 months post injection
Plan to share: No — Publication
Ran from Nov 2018 to primary completion in Aug 2019, 8 months.
Of 34 phase 1/2 interventional studies under Osteoarthritis, Knee, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's 8 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.