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

Osteoarthritis of the Knee Clinical Trial

Official title:

Adipose Derived Stromal Cell (ADSC) Injections for Pain Management of Osteoarthritis in the Human Knee Joint

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02357485
• Other study ID #: OAKnee01
• Status: Completed
• Phase: Phase 1
• First received: January 31, 2015
• Last updated: June 26, 2015
• Start date: March 2014
• Est. completion date: May 2015

Study information

• Verified date: June 2015
• Source: Fodor, Peter B, M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Biological:
• ADSC
Single injection of ADSC

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Fodor, Peter B, M.D.	Plastic Surgery Education and Research Foundation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety as Measured by Adverse Events	Adverse Events were recorded during the entirety of the study.	Entire Study (1 year)	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No