The Effect of Adipose-Derived Stem Cells for Knee Osteoarthritis

Study Purpose

The purpose of this study is to compare the clinical and functional outcomes of patients with mild to moderate arthroscopically confirmed osteoarthritis between the following two groups: 1. Partial fat pad harvest with Adipose-Derived Stem Cell (ADSC) transplantation with standard arthroscopic treatment consisting of: partial meniscectomy, cartilage stabilization, loose body removal and selective synovectomy. 2. Standard arthroscopic treatment (above) without cell transplant.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
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 - 70 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Age between 35 and 70 years-old.

- Patient is scheduled to undergo one or a combination of the following procedures: - Meniscal debridement or partial menisectomy.

- Meniscal repair that does not necessitate a different postoperative protocol from meniscal debridement or partial menisectomy.

- Removal of loose bodies.

- Chondroplasty.

- Synovectomy.

- Soft tissue releases for flexion or extension contracture.

- Diagnosis of pre-existing mild to moderate osteoarthritis of the medial or lateral femoral condyle (Kellgren-Lawrence Grade 2 or 3) - < 6 months of knee pain or < 6 months of a significant exacerbation of existing knee pain.

- Physical examination findings consistent with the proposed surgical procedure.

- Failure of conservative therapy consisting of a minimum of 6 weeks of physical therapy and trial of anti-inflammatory medications, with or without concomitant bracing and/or injections.

Exclusion Criteria:

- Age < 35 or > 70 years old.

- Radiographs demonstrating either no, little or severe osteoarthritis (Kellgren-Lawrence Grade 0, 1 or 4) - Previous injury or surgery to the infrapatellar fat pad (assessed by MRI) - Patient scheduled to undergo any concomitant surgical procedures with the exception of: - Meniscal debridement or partial menisectomy.

- Meniscal repair that does not necessitate a different postoperative protocol from meniscal debridement or partial menisectomy.

- Removal of loose bodies.

- Chondroplasty.

- Synovectomy.

- Soft tissue releases for flexion or extension contracture.

- Prior surgery on ipsilateral knee involving cartilage regeneration (microfracture, Autologous Chondrocyte Implantation, etc) or meniscal transplant/implant.

- Previous arthroscopy within 1 year.

- Subchondral edema

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.	NCT03014401
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.	University of Colorado, Denver
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Jason L Dragoo, MDSeth L Sherman, MD
Principal Investigator Affiliation	University of Colorado - Anschutz Medical CampusStanford University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Knee Osteoarthritis

Additional Details

Adipose-derived stem cells (ADSC) may be beneficial to patients with OA because they may differentiate into chondrocytes, promote endogenous tissue repair, and have potent anti-inflammatory properties. Early studies show promising clinical results using ADSCs to treat patients with osteoarthritis, but no clinical trials have been completed comparing cellular therapy to standard arthroscopic treatment. The investigators aim to determine whether ADSC transplantation as adjuvant therapy in patients with arthroscopic findings of mild to moderate arthritis will result in improved clinical outcomes scores at one and two-year follow-up compared to standard arthroscopic treatment.

Arms & Interventions

Arms

Experimental: Stem Cells

Fat pad harvest with stem cell transplantation and standard arthroscopic debridement.

Active Comparator: Placebo

Standard arthroscopic debridement with fat pad harvest WITHOUT stem cell transplantation

Interventions

Procedure: - Arthroscopic debridement with stem cell transplantation

Autologous fat pad harvest and transplantation of cells after standard arthroscopic treatment consisting of: partial meniscectomy, synovectomy, chondroplasty, loose body removal.

Procedure: - Arthroscopic debridement only

standard arthroscopic treatment consisting of: partial meniscectomy, synovectomy, chondroplasty, loose body removal.

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.

Kerlan Jobe Orthopedic Institute, Santa Monica, California

Status

Recruiting

Address

Kerlan Jobe Orthopedic Institute

Santa Monica, California, 90404

Site Contact

Jasmine Galloway, B.S.

[email protected]

310-829-2663

Stanford University, Stanford, California

Status