Autologous Adipose-Derived Stromal Vascular Fraction Cells for Osteoarthritis Treatment
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|ClinicalTrials.gov Identifier: NCT02967874|
Recruitment Status : Recruiting
First Posted : November 18, 2016
Last Update Posted : February 7, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis Joint Disease Osteoarthritis,Knee Arthritis, Degenerative Osteoarthrosis Osteoarthrosis Deformans||Procedure: Intra-articular auto-SVFs injection Drug: Hyaluronic Acid||Phase 1 Phase 2|
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=20) 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=20) 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety/Efficacy of Intra-articularly Administrated Autologous Adipose -Derived Stromal Vascular Fraction Cells in Treatment of Knee Osteoarthritis|
|Study Start Date :||March 2016|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||November 2019|
Experimental: Intra-articular auto-SVFs injection
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=20) will receive a single injection of auto-SVFs into affected knees (3.0 mL cell suspension/joint).
Procedure: Intra-articular auto-SVFs injection
Liposuction under local anesthesia followed by single intra-articular injection of auto-SVFs under the ultrasound navigation
Active Comparator: Intra-articular Hyaluronic Acid
This group of subjects (n=20) will receive a single injection of Synocrom Forte 2% into affected knees (1.0 mL/joint).
Drug: Hyaluronic Acid
Single intra-articular injection of Synocrom Forte 2% under the ultrasound navigation
Other Name: Synocrom Forte
- The number of patients with adverse events [ Time Frame: up to 12 months after treatment ]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
- Change in pain score on the Visual Analogue Scale (VAS) at all follow-up visits [ Time Frame: Baseline, 1, 3, 6 and 12 months after treatment ]The severity of joint pain, which is determined by the patient from 0 (no pain) to 10 points (unbearable pain), will be evaluated.
- Change in Knee injury and Osteoarthritis Outcome Score (KOOS) at all follow-up visits [ Time Frame: Baseline, 1, 3, 6 and 12 months after treatment ]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.
- Change in Ultrasonography of the knee joints [ Time Frame: Baseline, 3, 6 and 12 months after treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02967874
|Contact: Natalia M Starostina, PhD||+7 (383) email@example.com|
|Contact: Yuri A Kozhevnikov, PhD||+7 (383) firstname.lastname@example.org|
|Institute of Fundamental and Clinical Immunology||Recruiting|
|Novosibirsk, Russian Federation, 630099|
|Contact: Elena R Chernykh, MD, PhD +7 (383) 236-03-29 email@example.com|
|Contact: Alexander A Ostanin, MD, PhD +7 (383) 236-03-29 firstname.lastname@example.org|
|Study Chair:||Elena R Chernykh, MD, PhD||Institute of Fundamental and Clinical Immunology|
|Principal Investigator:||Alexander A Ostanin, MD, PhD||Institute of Fundamental and Clinical Immunology|