ADSC
BiologicalSingle injection of ADSC
NCT Number: NCT02357485
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.
Looking for future studies?
Notify Me20 year–70 year
All sexes
Interventional
Phase 1
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Single injection of ADSC
Time frame: Entire Study (1 year)
Adverse Events were recorded during the entirety of the study.
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)
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).
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.
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.
Fodor, Peter B, M.D.
Indiv
Adipose Derived Stromal Cell (ADSC) Injections for Pain Management of Osteoarthritis in the Human Knee Joint
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07193368
Arthritis, Degenerative Joint Disease of the Knee
Ankara, Turkey (Türkiye)
View Trial DetailsNCT06588972
Arthritis, Joint Diseases
Foz do Iguaçu, Paraná, Brazil
View Trial DetailsNCT06717529
Arthritis, Joint Diseases
Mostar, Bosnia and Herzegovina
View Trial DetailsNCT02611466
Arthritis, Chronic Lower Back Pain
Leuven, Belgium
View Trial Details