ADSC Injections for Pain Management of Osteoarthritis in the Human Knee Joint

Phase 1

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

voluntarily provided written Informed Consent
ages 20-70
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 -

Exclusion Criteria

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
end stage (Grade IV) OA

Arm && Interventions

Group	Intervention	Description
Treatment arm	ADSC	Single injection of ADSC

Primary Outcome Measures

Name	Time	Method
Safety as Measured by Adverse Events	Entire Study (1 year)	Adverse Events were recorded during the entirety of the study.

Secondary Outcome Measures

Name	Time	Method
Comparison of Baseline Score and 3 Months Score in Timed-Up-and-Go (TUG).	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.
Comparison of Baseline Score and 1 Year Score in Western Ontario and McMaster Universities Arthritis Index (WOMAC)	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 and 3 Months Measures of Knee Flexion for Range of Motion	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 1 Year Score in Visual Analog Scale (VAS) for Pain	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).