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

Fodor, Peter B, M.D.6 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Osteoarthritis of the Knee

Interventions

ADSCBIOLOGICAL

Single injection of ADSC

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Safety as Measured by Adverse Events

Adverse Events were recorded during the entirety of the study.

Time frame: Entire Study (1 year)

Secondary Outcomes

Comparison of Baseline Score and 1 Year Score in Western Ontario and McMaster Universities Arthritis Index (WOMAC)

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 Baseline Score and 1 Year Score in Visual Analog Scale (VAS) for Pain

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 1 year

Comparison of Baseline and 3 Months Measures of Knee Flexion for Range of Motion

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 Score and 3 Months Score in Timed-Up-and-Go (TUG).

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.

Time frame: baseline to 3 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.