Overview

Autologous Adipose-Derived Stromal Vascular Fraction Cells for Osteoarthritis Treatment

Status:
Completed
Trial end date:
2019-09-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Russian Academy of Medical Sciences
Treatments:
Hyaluronic Acid
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