Adipose-derived SVF for the Treatment of Knee OA

NCT02726945 | Completed Results DMC

• 1 other identifier: GIDOA-01
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 3

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.

Conditions

Osteoarthritis (OA)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  baseline and 6 months

Study Arms (3)

Low Dose SVF

EXPERIMENTAL

This group of subjects will receive a low dose of SVF for treatment of knee OA.

Device: GID SVF-2

High Dose

EXPERIMENTAL

This group of subjects will receive a high dose of SVF for treatment of knee OA.

Device: GID SVF-2

Placebo

PLACEBO COMPARATOR

This group of subjects will receive a placebo with no SVF Cells for treatment of knee OA.

Other: Placebo

Interventions

GID SVF-2 DEVICE

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.

High Dose; Low Dose SVF

Placebo OTHER

Placebo Control

Placebo

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GID BIO, Inc.: lead

Study Sites (3)

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

Rothman Institute

Egg Harbor, New Jersey, 08234, United States

Location

Texas Plastic Surgery

San Antonio, Texas, 78240, United States

Location

Related Publications (3)

• 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.

  PMID: 26238455 BACKGROUND

• 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)

  BACKGROUND

• Garza JR, Campbell RE, Tjoumakaris FP, Freedman KB, Miller LS, Santa Maria D, Tucker BS. Clinical Efficacy of Intra-articular Mesenchymal Stromal Cells for the Treatment of Knee Osteoarthritis: A Double-Blinded Prospective Randomized Controlled Clinical Trial. Am J Sports Med. 2020 Mar;48(3):588-598. doi: 10.1177/0363546519899923.

  PMID: 32109160 DERIVED

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Director of Clinical Operations
• Organization: GID Bio

s.samudre@gidbio.com

3039524901

Study Officials

• Victoria Good, PhD

  GID BIO, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2016
• First Posted: April 4, 2016
• Study Start: April 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: October 1, 2019
• Last Updated: April 25, 2025
• Results First Posted: August 21, 2019

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)