The Effect of Adipose-Derived Stem Cells for Knee Osteoarthritis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03014401|
Recruitment Status : Recruiting
First Posted : January 9, 2017
Last Update Posted : November 27, 2020
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:
- 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.
- Standard arthroscopic treatment (above) with out cell transplant.
|Condition or disease||Intervention/treatment||Phase|
|Knee Osteoarthritis||Procedure: Arthroscopic debridement with stem cell transplantation Procedure: Arthroscopic debridement only||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||29 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||The Effect of Adipose-Derived Stem Cells for Knee Osteoarthritis: A Randomized Controlled Trial|
|Study Start Date :||May 2016|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||December 2021|
Experimental: Stem Cells
Fat pad harvest with stem cell transplantation and standard arthroscopic debridement.
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.
Active Comparator: Placebo
Standard arthroscopic debridement with fat pad harvest WITHOUT stem cell transplantation
Procedure: Arthroscopic debridement only
standard arthroscopic treatment consisting of: partial meniscectomy, synovectomy, chondroplasty, loose body removal.
- Postoperative KOOS (Knee Injury and Osteoarthritis Outcome Score) score 24 months following surgery [ Time Frame: The study will end after 24 month follow-up is completed in all participants. ]Patient reported outcomes measures; Score ranges 0-100, with 100 being healthy/normal
- Tegner score [ Time Frame: 6, 12, 24 months ]Patient reported outcomes measures
- Lysholm score [ Time Frame: 6, 12, 24 months ]Patient reported outcomes measures
- VR-12 [ Time Frame: 6, 12, 24 months ]Patient reported outcomes measures
- MRI scans - [ Time Frame: 1, 12, 24 months ]Average cartilage thickness. Defect fill (percent) routine clinical sequences, T2, T1p
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03014401
|United States, California|
|Kerlan Jobe Orthopedic Institute||Recruiting|
|Santa Monica, California, United States, 90404|
|Contact: Jasmine Galloway, B.S. 310-829-2663 email@example.com|
|Sub-Investigator: Burt Mandelbaum, M.D.|
|Stanford University||Active, not recruiting|
|Stanford, California, United States, 94305|
|United States, Colorado|
|UC Health Steadman Hawkins Clinic - Denver Inverness||Recruiting|
|Denver, Colorado, United States, 80112|
|Contact: Alexandra D Orahovats, MS 720-516-9824 firstname.lastname@example.org|
|Principal Investigator:||Jason L Dragoo, MD||University of Colorado - Anschutz Medical Campus|
|Principal Investigator:||Seth L Sherman, MD||Stanford University|