ADSC Injections for Pain Management of Osteoarthritis in the Human Knee Joint
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
This safety and feasibility study used autologous adipose-derived stromal cells (ADSC), the stromal vascular fraction (SVF), to treat 8 osteoarthritic (OA) knees in 6 patients of grade I to III (K-L scale) with initial pain of 4 or greater on a 10 point scale, under Institutional Review Board (IRB) approved protocol.
Condition or disease
Osteoarthritis of the Knee
This safety and feasibility study used autologous adipose-derived stromal cells, the stromal vascular fraction, to treat 8 osteoarthritic knees in 6 patients of grade I to III (K-L scale) with initial pain of 4 or greater on a 10 point scale, under IRB-approved protocol. Evaluation of the safety of intra-articular injection of the stromal vascular fraction cells was the primary objective of the study. Adipose-derived stromal vascular cells were obtained through enzymatic disaggregation of lipoaspirate, resuspended in 3 ml of Lactated Ringer's Solution, and injected directly into the intra-articular space with a mean of 12 million viable nucleated SVF cells per knee.
Safety as Measured by Adverse Events [ Time Frame: Entire Study (1 year) ]
Adverse Events were recorded during the entirety of the study.
Secondary Outcome Measures :
Comparison of Baseline Score and 1 Year Score in Western Ontario and McMaster Universities Arthritis Index (WOMAC) [ Time Frame: Baseline to 1 year ]
Comparison of WOMAC score (pain, stiffness and functionality measures) measured at baseline (pre-treatment), 3 months and 1 year (post treatment).
WOMAC score: 0 (best) to 100 (worst)
Comparison of Baseline Score and 1 Year Score in Visual Analog Scale (VAS) for Pain [ Time Frame: Baseline to 1 year ]
Comparison of VAS pain score as measured before treatment and 3 months and 1 year after treatment. VAS measured on a scale of 0 (no pain) to 10 (worst possible pain).
Comparison of Baseline and 3 Months Measures of Knee Flexion for Range of Motion [ Time Frame: Baseline to 3 months ]
Comparison of baseline measure of knee flexion to 3 months measurements of knee flexion. An increase in range of motion is positive (improved ability to move) and a decrease in range of motion is negative.
Comparison of Baseline Score and 3 Months Score in Timed-Up-and-Go (TUG). [ Time Frame: baseline to 3 months ]
Comparison of baseline time for subjects' ability to rapidly rise from a chair, move rapidly 2 meters from the chair, turn and return and sit in the chair to the same measure at 3 months. Time to complete task is measured in seconds.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
20 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
voluntarily provided written Informed Consent
male or female
grades I-III radiologically documented OA of one or both knees
American Society Anaesthesiologists (ASA) physical status class I-II and a • BMI less than 35
knee pain graded as greater than 3 out of 10 on screening questionnaire
able to speak, read and understand English -
patient parameters falling outside of the inclusion criteria
current oral or parenteral steroid or blood thinner use
hyaluronic acid-based injection to the affected knee joint within the previous six months
corticosteroid injection to the affected knee joint within the previous three months