Recruiting

Adipose Tissue

Sponsor:

University of Southern California

Code:

NCT03242707

Conditions

Osteoarthritis, Knee

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

Interventions

Autologous adipose tissue injection

Hyaluronic Acid

Study Details

Brief summary:

A new generation of "minimally manipulated" regenerative treatments are being offered at clinics across the country, but there is no strong efficacy data to support their use. The purpose of this study is to estimate the effect size of the treatment by comparing the efficacy of autologous fat to the current standard of care treatment, hyaluronic acid (HA). As a secondary aim, we will test for preliminary evidence of efficacy of autologous fat vs. HA and determine how these treatments effect the biochemical environment of the knee by comparing pre-injection and post-injection synovial fluid biomarker profiles.

Conditions

Osteoarthritis, Knee

Study ID

NCT03242707

Start date

Jul 1, 2018

Status verified date

Oct, 2019

Completion date

Dec 1, 2020

Anticipated

Primary completion date

Dec 1, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age 45 to 75, inclusive
2. Normal axial alignment
3. X-ray, Kellgren-Lawrence OA grade 2 - 3, inclusive
4. WOMAC-pain: Between 9 and 19, inclusive
5. Willingness to participate all scheduled follow-ups
6. Willingness to refrain from taking NSAIDs, level 2 analgesics, and opioids for the course of the study
7. BMI < 40

Exclusion Criteria:

1. Pregnant or lactating
2. Intra-articular injection within 3 months of treatment
3. Inflammatory arthritis
4. Any disease or active drug use that significantly compromises coagulation
5. Significant damage and/or tears of the ACL or other supporting tissues
6. Prior knee surgery in the last 6 months in the knee that will be injected
7. Active tobacco use
8. Active alcohol or substance abuse within 6 months of study entry
9. Known hypersensitivity (allergy) to hyaluronan (sodium hyaluronate) preparations
10. Knee joint infections, skin diseases or infections in the area of the injection site
11. Diabetes
12. Active inhaler use
13. Any medical condition, which in the opinion of the clinical investigator, would interfere with the treatment or outcome evaluation

Study Design

Enrollment

54 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Autologous adipose tissue knee injection

Fat will be removed from the abdomen and processed using the Lipogems device. Approximately 5ml of the microfragmented fat product will be injected into the knee joint.

active comparator: Hyaluronic Acid knee injection

Hyaluronic Acid - Synvisc-One®: A high molecular weight sodium hyaluronate (HA). HA is an FDA approved, standard of care treatment.

Interventions

Autologous adipose tissue injection

20ml to 40ml of subcutaneous adipose tissue will be aspirated from the abdomen. Adipose tissue will be processed using the Lipogems device, a closed-loop processing device used in medical procedures involving the harvesting, concentrating and transferring of autologous adipose tissue.

The resulting fat product will be delivered locally via ultrasound-guided, intra-articular injection.

Hyaluronic Acid

Synvisc-One® is a high molecular weight sodium hyaluronate.

Primary outcome measure

  • The pain items of then Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC-A) [ Time Frame: Change from baseline WOMAC score at 6 months ]

Central Contacts and Locations

Central contacts

William Fang

323-442-6959williahf@usc.edu

Locations

Keck Medicine of USC

Recruiting

Los Angeles, California, United States, 90033

Contacts

William Fang

323-442-6959williahf@usc.edu

More Information

Sponsor

University of Southern California

Last update posted

Oct 3, 2019

Last verified

Oct, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Southern California on 2019-10-03.