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

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis of the Knee
• Intervention / Treatment: Biological: ADSC

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment arm; Single injection of ADSC	Biological: ADSC; Single injection of ADSC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety as Measured by Adverse Events	Adverse Events were recorded during the entirety of the study.	Entire Study (1 year)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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).	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.	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.	baseline to 3 months

Collaborators and Investigators

• Sponsor: Fodor, Peter B, M.D.
• Collaborators: Plastic Surgery Education and Research Foundation
• Investigators: Principal Investigator: Peter B Fodor, M.D., Private Practice

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: January 31, 2015
• First Submitted That Met QC Criteria: February 5, 2015
• First Posted (Estimate): February 6, 2015

Study Record Updates

• Last Update Posted (Estimate): June 30, 2015
• Last Update Submitted That Met QC Criteria: June 26, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: osteoarthritis; knee; adipose; ADSC
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: OAKnee01