A Phase 1/2 interventional study of Intra-articular auto-SVFs injection and Hyaluronic Acid in Osteoarthritis, Joint Disease and Osteoarthritis,Knee, sponsored by Russian Academy of Medical Sciences. Completed at 1 site in Russian Federation. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-09-13.
Sponsored by Russian Academy of Medical Sciences · Phase 1/2, Interventional, and Treatment
Adipose-derived stromal vascular fraction cells (SVFs) include regenerative cell populations (hematopoietic cells, pericytes, endothelial cells and progenitors, stromal/stem cells) and thus are potentially important as new therapeutic tools for the repair and regeneration of acute and chronically damaged tissues.
The general objective of this study is to evaluate safety and clinical efficacy of a single intra-articular injection of freshly isolated auto-SVFs for the treatment of patients with knee osteoarthritis (OA). This study uses autologous adipose-derived SVFs, as therapeutic agent and intra-articular administration, as a mode of delivery. Expected clinical effects: a treatment reduces pain, increases function and reduces stiffness in the knees of osteoarthritic subjects.
Subcutaneous human adipose tissue is an abundant and accessible cell source for applications in tissue engineering and regenerative medicine. Methods to extract stromal/stem cells from the waste products of abdominoplasty, cosmetic surgery, and liposuction are now well developed. Routinely, the adipose tissue is digested with collagenase or related enzymes to release a heterogeneous population of SVF cells. The SVF cells can be used directly or can be cultured in plastic ware to select and expand an adherent population known as adipose-derived stromal/stem cells.
Osteoarthritis is the most common joint disease that affects at least 20% of the world population. The disease usually begins at the age of 40 years. Radiographic signs of osteoarthritis are diagnosed in 50% of people aged 55 years and 80% - over 75 years. OA can cause severe pain and stiffness in the affected joints, thus reducing joint's functionality. Therefore a treatment that would reduce pain/stiffness and increase joint function would be of benefit to many people. Safety and feasibility of SVFs in OA patients have been shown in few clinical studies.
This trial is a prospective, controlled, non-randomized, non-blinded, interventional study to determine safety and efficacy of a single injection of freshly isolated autologous SVFs into the knees of osteoarthritic patients (Grade II-III). In experimental group the participants (n=16) will undergo a standard liposuction to harvest adipose tissue, then the adipose tissue will be processed to obtain the SVFs and patients will receive a single intra-articular injection of auto-SVFs into affected knees under the ultrasound navigation. In parallel control group the participants (n=11) will receive a single intra-articular injection of hyaluronic acid (Synocrom Forte 2%) under the ultrasound navigation. The safety of auto-SVFs injection will be evaluated by assessment of the frequency and nature of adverse events occurring during or immediately after the procedure, and up to the one year following treatment. Patients will be monitored during 1, 3, 6 and 12- month's visits.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 27 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Russian Academy of Medical Sciences is the lead sponsor of 34 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The participants will undergo a standard liposuction to harvest adipose tissue. The adipose tissue will then be processed to obtain the SVFs. This group of subjects (n=16) will receive a single injection of auto-SVFs into affected knees (3.0 mL cell suspension/joint).
Procedure: Intra-articular auto-SVFs injection
This group of subjects (n=11) will receive a single injection of Synocrom Forte 2% into affected knees (1.0 mL/joint).
Drug: Hyaluronic Acid
Liposuction under local anesthesia followed by single intra-articular injection of auto-SVFs under the ultrasound navigation
Single intra-articular injection of Synocrom Forte 2% under the ultrasound navigation
Also known as: Synocrom Forte
The number of patients with adverse events
The safety of intra-articular injection of auto-SVFs will be evaluated by assessment of the frequency and nature of adverse events during or immediately after the procedure, and up to the 12-months following treatment
Time frame: up to 12 months after treatment
Change in pain score on the Visual Analogue Scale (VAS) at all follow-up visits
The severity of joint pain, which is determined by the patient from 0 (no pain) to 10 points (unbearable pain), will be evaluated.
Time frame: Baseline, 1, 3, 6 and 12 months after treatment
Change in Knee injury and Osteoarthritis Outcome Score (KOOS) at all follow-up visits
KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). Standardized answer options are given and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Time frame: Baseline, 1, 3, 6 and 12 months after treatment
Change in Ultrasonography of the knee joints
Time frame: Baseline, 3, 6 and 12 months after treatment
This study is completed, as verified in Sep 2019. 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.
Russian Academy of Medical Sciences