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

Fodor, Peter B, M.D.

Status and phase

Completed

Phase 1

Conditions

Osteoarthritis of the Knee

Treatments

Biological: ADSC

Study type

Interventional

Funder types

Other

Identifiers

NCT02357485

OAKnee01

Details and patient eligibility

About

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.

Full 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.

Enrollment

6 patients

Sex

All

Ages

20 to 70 years old

Volunteers

Accepts Healthy Volunteers

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