Clinical trial NCT02726945: Adipose-derived SVF for the Treatment of Knee OA
Official title: Use of Autologous Adipose-Derived Stromal Vascular Fraction to Treat Osteoarthritis of the Knee: A Controlled, Randomized, Double-Blinded Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis (OA)
Lead sponsor: GID BIO, Inc.
Sponsor class: INDUSTRY
First posted: 2016-04-04
Enrollment: 39
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 \< 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

Primary outcomes:
measure: Safety - Number of Participants With Treatment-Emergent Serious Adverse Events
timeFrame: up to 1 year
Secondary outcomes:
measure: Efficacy - Percent Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score From Baseline to 6 Months
timeFrame: baseline and 6 months
Other outcomes:
Locations:
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: Egg Harbor Township
country: United States
facility: Rothman Institute
state: New Jersey
city: San Antonio
country: United States
facility: Texas Plastic Surgery
state: Texas
Study officials:
affiliation: GID BIO, Inc.
name: Victoria Good, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
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)
citation: 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.