Adipose-derived SVF for the Treatment of Knee OA

Not Applicable

Completed

Conditions: Osteoarthritis (OA)

Interventions: Device: GID SVF-2
Other: Placebo

Registration Number: NCT02726945

Lead Sponsor: GID BIO, Inc.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 39

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 < 35.
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.
Subjects with chondrocalcinosis, Paget's disease and Villonodular synovitis
Subjects that use any form of tobacco
Women that are pregnant or planning to become pregnant during the study.
Subjects on long term use of oral steroids
History of any chemotherapy or radiation therapy of the targeted/treatment leg or adipose harvest site.
Subjects currently on worker's compensation

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Dose SVF	GID SVF-2	This group of subjects will receive a low dose of SVF for treatment of knee OA.
Placebo	Placebo	This group of subjects will receive a placebo with no SVF Cells for treatment of knee OA.
High Dose	GID SVF-2	This group of subjects will receive a high dose of SVF for treatment of knee OA.

Primary Outcome Measures

Name	Time	Method
Safety - Number of Participants With Treatment-Emergent Serious Adverse Events	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 Outcome Measures

Name	Time	Method
Efficacy - Percent Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score From Baseline to 6 Months	baseline and 6 months	The primary efficacy will be achieved if either dose group is shown to be superior to the placebo group at 6 months post-treatment, using the percent change in WOMAC score from baseline as the primary variable. The WOMAC score consists of 3 subscales, pain, stiffness and function. The overall score is normalized to a range of 0 to 100 points with a lower score indicating less symptoms of osteoarthritis.

Trial Locations

Locations (3): Texas Plastic Surgery
🇺🇸
San Antonio, Texas, United States
Rothman Institute
🇺🇸
Egg Harbor Township, New Jersey, United States
Cooper University Hospital
🇺🇸
Camden, New Jersey, United States