Title
ADSC Injections for Pain Management of Osteoarthritis in the Human Knee Joint
Adipose Derived Stromal Cell (ADSC) Injections for Pain Management of Osteoarthritis in the Human Knee Joint
Phase
Phase 1Lead Sponsor
Fodor, Peter B, M.D.Study Type
InterventionalStatus
Completed Results PostedIndication/Condition
Osteoarthritis of the KneeIntervention/Treatment
allogeneic adipose derived mesenchymal stem cell ...Study Participants
6This 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.
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.
Single injection of ADSC
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
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Adverse Events were recorded during the entirety of the study.
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 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 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 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.
