Autologous Adipose-derived Stromal Vascular Fraction for Treatment of Knee Osteoarthritis

Study Purpose

This study is a pivotal study to evaluate the efficacy and safety of a single injection of autologous adipose-derived SVF produced using the GID SVF-2 device system for treatment of pain with concomitant improvement in function associated with osteoarthritis of the knee joint.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 35 Years - 85 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Bilateral or unilateral knee osteoarthritis as diagnosed on pre-op MRI using the Outerbridge Cartilage Classification as Grade II, Grade III, or Grade IV with full thickness lesion of the articular cartilage is less than 1.5 cm in any direction.
  • - Index knee must present with a score ≥8 using the WOMAC pain scale (A1 subscale, 20 total points) - 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.
  • - Males and females 35-85 years old.
  • - Subjects with BMI ≥22 and ≤ 37.
  • - Subjects must speak, read and understand English.
  • - Subjects must be able to return for multiple follow-up visits.

Exclusion Criteria:

  • - Subjects whose knee pain is caused by: - unstable meniscal root tears or locked bucket handle meniscal tears.
  • - displaced meniscus tear.
  • - full thickness lesion of the articular cartilage greater than 1.5 cm in any direction.
  • - osteo chondritis dissecans.
  • - parameniscal, Baker's, or ganglion cysts.
  • - lipoma arborescens.
  • - Hoffa's Pad Syndrome.
  • - acute ligament tears.
  • - diffuse edema.
  • - pain due to patellar mal-tracking or patellar dislocations.
  • - Outerbridge Scale Grade I as diagnosed on MRI.
  • - Outerbridge Scale Grade IV where the full thickness lesion of the articular cartilage is greater than 1.5 cm in any direction, as diagnosed on MRI.
  • - Subjects who have had surgery of either knee within 6 months prior to the surgery visit.
  • - Subjects who have had a major injury to either knee within 12 months prior to the surgery visit.
  • - Subjects who have had an injection in either knee in the prior 6 months, including corticosteroids, viscosupplementation, stromal vascular fraction (SVF), bone marrow stem cells, or platelet rich plasma.
  • - 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 that are unwilling to stop taking prescription or over the counter pain medication 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 follows prior to injection; thrombolytics and anti-platelet medication including but not limited to Coumadin (warfarin) for 3 days, Plavix (colpidogrel) for 3 days, ASA/NSAIDs/fish oil supplements for 7 days, Xeralta® (rivaroxaban) for 24 hours.
  • - Subjects with systemic immunosuppressant use within 6 weeks from screening and subjects with HIV or viral hepatitis.
  • - Subjects with chondrocalcinosis, Paget's disease or Villonodular synovitis.
  • - Subjects that use any form of tobacco, including e-cigarettes, more than once a week over the most recent 1 year period.
  • - 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 on either leg or adipose harvest site.
- Subjects currently on worker's compensation

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04440189
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

GID BIO, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

William Cimino, PhD
Principal Investigator Affiliation GID BIO
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Osteoarthritis, Knee
Additional Details

This is a prospective, randomized, placebo controlled, parallel groups, double blind, multi-center, interventional study of subjects with osteoarthritis of the knee. Subjects will be randomized to receive an injection of LR (placebo) or SVF derived from their own adipose tissue (experimental).

Arms & Interventions

Arms

Placebo Comparator: Placebo

Subjects will receive an injection of Lactated Ringers in their index knee

Experimental: Stromal Vascular Fraction (SVF)

Subjects will receive an injection of Stromal Vascular Fraction in their index knee

Interventions

Device: - GID SVF-2 Device System

The GID SVF-2 Device System is used for harvesting, filtering, separating and concentrating autologous stromal vascular fraction from adipose tissue.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Shrock Orthopaedic Research, Fort Lauderdale, Florida

Status

Recruiting

Address

Shrock Orthopaedic Research

Fort Lauderdale, Florida, 33316

Site Contact

Jennifer Motes, CRC

[email protected]

954-626-3743

Tulane University, New Orleans, Louisiana

Status

Recruiting

Address

Tulane University

New Orleans, Louisiana, 70112

Site Contact

Emily Callegari

[email protected]

504-988-0200

New Jersey Regenerative Institute, Cedar Knolls, New Jersey

Status

Recruiting

Address

New Jersey Regenerative Institute

Cedar Knolls, New Jersey, 07927

Site Contact

Shalaka Paranjpe

[email protected]

973-998-8301

San Antonio, Texas

Status

Recruiting

Address

Texas Center for Cell Therapy and Research

San Antonio, Texas, 78240

Site Contact

Jennifer Krieger

[email protected]

210-616-0301