Use of Autologous Adipose-Derived Stromal Vascular Fraction to Treat Osteoarthritis of the Knee: A Controlled, Randomized, Double-Blinded Trial

GID BIO, Inc.3 sites in 1 country39 target enrollmentApril 2016

ConditionsOsteoarthritis (OA)

Overview

Phase: N/A
Intervention: Not specified
Conditions: Osteoarthritis (OA)
Sponsor: GID BIO, Inc.
Enrollment: 39
Locations: 3
Primary Endpoint: Safety - Number of Participants With Treatment-Emergent Serious Adverse Events
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a pivotal study. The study will examine the safety and efficacy of autologous adipose-derived stromal vascular fraction (SVF) cells processed with the GID SVF-2 device for pain, function and stiffness in the knees of osteoarthritic subjects.

Detailed Description

Osteoarthritis is the main form of arthritis and affects over 20 million people in the United States. In the knee it can cause severe pain, reduced functionality and increased stiffness thus, a treatment that would reduce pain, increase function and reduce stiffness would be of benefit to many people. This study will collect and disassociate adipose tissue and inject the stromal vascular fraction into the knee of the same patient. The study is controlled, randomized and double-blinded with 2 SVF treatments (high and low dose) and a placebo control.

Registry

clinicaltrials.gov

Start Date

April 2016

End Date

October 1, 2019

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GID BIO, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Grade II or Grade III osteoarthritis using Kellgren-Lawrence grading scale (K-L Grade) as diagnosed using weight bearing X-ray, physician review, and/or pre-op MRI.
•Study Subjects must have failed a minimum of at least two conservative therapies, spanning a period of at least 3 months.
•Study Subjects must be willing to voluntarily give written Informed Consent to participate in the study and sign the Health Insurance Portability and Accountability Act (HIPAA) authorization before any study procedures are performed.
•Subjects will be in good health (ASA Class I-II) with a BMI \<
•Subjects must have continued pain in the knee despite conservative therapies for at least 3 months.
•Subjects with unilateral disease must present with symptomatic knee pain using the WOMAC subscale for pain.
•Subjects must speak, read and understand English.
•Subjects must be reasonably able to return for multiple follow-up visits.

Exclusion Criteria

•Subjects whose knee pain is caused by, (i) diffuse edema, (ii) displaced meniscus tear, (iii) lesion greater than 1 cm in any direction, or (iv) osteochondritis dissecans.
•Subjects who have had surgery of either knee within 6 months prior to the screening visit.
•Subjects who have had a major injury to the targeted knee within 12 months prior to enrolling in the study.
•Subjects who have had an injection in either knee in the prior 3 months, including corticosteroids, viscosupplementation or platelet rich plasma (PRP).
•Subjects who have gout, rheumatoid arthritis, lupus arthropathy, psoriatic arthritis, avascular necrosis, severe bone deformity, infection of the knee joint, fibromyalgia, pes anserine bursitis, or neurogenic or vascular claudication.
•Subjects who have symptomatic OA of the hips, spine, or ankle that would interfere with the evaluation of the treated knee.
•Subjects that are unwilling to stop taking prescription or over the counter pain medication for 7 days prior to any visit
•Subjects that are allergic to lidocaine, epinephrine or valium
•Subjects with a history of bleeding disorders, anticoagulation therapy that cannot be stopped as prior to injection.
•Subjects with systemic immunosuppressant use within six (6) weeks from screening and subjects with HIV/viral hepatitis.

Outcomes

Primary Outcomes

Safety - Number of Participants With Treatment-Emergent Serious Adverse Events

Time Frame: up to 1 year

Subjects will be monitored for serious and device related adverse events. Baseline MRIs will be compared to 1 year for any abnormal findings.

Secondary Outcomes

Efficacy - Percent Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score From Baseline to 6 Months(baseline and 6 months)