Adipose-derived SVF for the Treatment of Knee OA

Osteoarthritis (OA) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02726945
• Other study ID #: GIDOA-01
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: October 1, 2019

Study information

• Verified date: February 2020
• Source: The GID Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: October 1, 2019
• Est. primary completion date: April 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis (OA)

Intervention

Device:
• GID SVF-2
The GID SVF-2 device is a sterile single-use disposable canister used for harvesting, filtering, separating, and concentrating autologous stromal vascular fraction cells from adipose tissue for reintroduction to the same patient during a single surgical procedure for treatment of pain associated with joint osteoarthritis.

Other:
• Placebo
Placebo Control

Locations

Country	Name	City	State
United States	Cooper University Hospital	Camden	New Jersey
United States	Rothman Institute	Egg Harbor Township	New Jersey
United States	Texas Plastic Surgery	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The GID Group

Country where clinical trial is conducted

United States, 

References & Publications (2)

Fodor PB, Paulseth SG. Adipose Derived Stromal Cell (ADSC) Injections for Pain Management of Osteoarthritis in the Human Knee Joint. Aesthet Surg J. 2016 Feb;36(2):229-36. doi: 10.1093/asj/sjv135. Epub 2015 Aug 3. — View Citation

Garza GR, Palomera T, Dumanian GA and Dos-Anjos S. Use of Autologous Adipose-derived Stromal Vascular Fraction to Treat Osteoarthritis of the Knee: A Feasibility and Safety study. J Regen Med. 2015;4(1)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety - Number of Participants With Treatment-Emergent Serious Adverse Events	Subjects will be monitored for serious and device related adverse events. Baseline MRIs will be compared to 1 year for any abnormal findings.	up to 1 year
Secondary	Efficacy - Percent Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score From Baseline to 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.	baseline and 6 months