Clinical trial NCT02967874: Autologous Adipose-Derived Stromal Vascular Fraction Cells for Osteoarthritis Treatment
Official title: Safety/Efficacy of Intra-articularly Administrated Autologous Adipose -Derived Stromal Vascular Fraction Cells in Treatment of Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Osteoarthritis
Joint Disease
Osteoarthritis,Knee
Arthritis, Degenerative
Osteoarthrosis
Osteoarthrosis Deformans
Keywords: Adipose -Derived Stromal Vascular Fraction Cells
Knee Osteoarthritis
Intra-articular Administration
Liposuction
Lead sponsor: Russian Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2016-11-18
Enrollment: 27
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age 40 to 85 Years (Adult, Senior)
* Grade II or Grade III osteoarthritis of the knee joints using Kellgren-Lawrence grading scale (K-L Grade) as diagnosed using weight bearing X-ray and physician review, and/or MRI
* Patients must have continued pain in the knee despite conservative therapies for at least 3 months
* Patients must be able to tolerate all study procedures
* Patients must be willing to voluntarily give written Informed Consent to participate in the study before any procedures are performed
* Patients must be willing to be available for all baseline, treatment and follow-up examinations required by protocol

Exclusion Criteria:

* Subjects with a BMI \> 35
* Subjects who have had an injection in either knee in the prior 4 weeks, including corticosteroids, drugs of hyaluronic acid or platelet rich plasma (PRP).
* Subjects who have had surgery of either knee within 6 months prior to the screening visit
* Subjects those are allergic to drugs for local anesthesia
* Psychiatric disorders
* Hepatic or renal dysfunctions
* Hemodynamic or respiratory instability
* HIV or uncontrolled bacterial, fungal, or viral infections
* Autoimmune diseases (rheumatoid arthritis, lupus arthropathy, psoriatic arthritis, etc)
* Pregnancy
* Malignancy
* Participation in other clinical trials

Primary outcomes:
measure: The number of patients with adverse events
timeFrame: up to 12 months after treatment
Secondary outcomes:
measure: Change in pain score on the Visual Analogue Scale (VAS) at all follow-up visits
timeFrame: Baseline, 1, 3, 6 and 12 months after treatment
measure: Change in Knee injury and Osteoarthritis Outcome Score (KOOS) at all follow-up visits
timeFrame: Baseline, 1, 3, 6 and 12 months after treatment
measure: Change in Ultrasonography of the knee joints
timeFrame: Baseline, 3, 6 and 12 months after treatment
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Institute of Fundamental and Clinical Immunology
Study officials:
affiliation: Institute of Fundamental and Clinical Immunology
name: Elena R Chernykh, MD, PhD
role: STUDY_CHAIR
affiliation: Institute of Fundamental and Clinical Immunology
name: Alexander A Ostanin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Michalek J, Moster R, Lukac L, Proefrock K, Petrasovic M, Rybar J, Capkova M, Chaloupka A, Darinskas A, Michalek J Sr, Kristek J, Travnik J, Jabandziev P, Cibulka M, Holek M, Jurik M, Skopalik J, Kristkova Z, Dudasova Z. WITHDRAWN: Autologous adipose tissue-derived stromal vascular fraction cells application in patients with osteoarthritis. Cell Transplant. 2015 Jan 20. doi: 10.3727/096368915X686760. Online ahead of print.
citation: Garza GR, Palomera T, Dumanian GA, Dos-Anjos S. Use of autologous adipose-derived stromal vascular fraction to treat osteoarthritis of the knee: a feasibility and safety study. J Regen Med. 4(1), 2015 doi:10.4172/2325-9620.1000119