Autologous Adipose-Derived Stromal Vascular Fraction Cells for Osteoarthritis Treatment

Osteoarthritis Clinical Trial

Official title:

Safety/Efficacy of Intra-articularly Administrated Autologous Adipose -Derived Stromal Vascular Fraction Cells in Treatment of Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02967874
• Other study ID #: IFCI-10/11/2015
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 2016
• Est. completion date: September 2019

Study information

• Verified date: September 2019
• Source: Russian Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: September 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis, Degenerative
• Joint Disease
• Joint Diseases
• Osteoarthritis
• Osteoarthritis, Knee
• Osteoarthritis,Knee
• Osteoarthrosis
• Osteoarthrosis Deformans

Intervention

Procedure:
• Intra-articular auto-SVFs injection
Liposuction under local anesthesia followed by single intra-articular injection of auto-SVFs under the ultrasound navigation

Drug:
• Hyaluronic Acid
Single intra-articular injection of Synocrom Forte 2% under the ultrasound navigation

Locations

Country	Name	City	State
Russian Federation	Institute of Fundamental and Clinical Immunology	Novosibirsk

Sponsors (1)

Lead Sponsor	Collaborator
Russian Academy of Medical Sciences

Country where clinical trial is conducted

Russian Federation, 

References & Publications (2)

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

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. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	up to 12 months after treatment
Secondary	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.	Baseline, 1, 3, 6 and 12 months after treatment
Secondary	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.	Baseline, 1, 3, 6 and 12 months after treatment
Secondary	Change in Ultrasonography of the knee joints		Baseline, 3, 6 and 12 months after treatment