Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : June 3, 2019
Sponsor:
Information provided by (Responsible Party):
Jason L. Dragoo, Stanford University

Tracking Information
First Submitted Date  ICMJE December 20, 2016
First Posted Date  ICMJE January 9, 2017
Last Update Posted Date June 3, 2019
Study Start Date  ICMJE May 2016
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 5, 2017)
Postoperative KOOS score 24 months following surgery [ Time Frame: The study will end after 24 month follow-up is completed in all participants. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03014401 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 5, 2017)
MRI scans - [ Time Frame: 1, 12, 24 months ]
Average cartilage thickness. Defect fill (percent) routine clinical sequences, T2, T1p
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Effect of Adipose-Derived Stem Cells for Knee Osteoarthritis
Official Title  ICMJE The Effect of Adipose-Derived Stem Cells for Knee Osteoarthritis: A Randomized Controlled Trial
Brief Summary

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) with out cell transplant.
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Knee Osteoarthritis
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Stem Cells
    Fat pad harvest with stem cell transplantation and standard arthroscopic debridement.
    Intervention: Procedure: Arthroscopic debridement with stem cell transplantation
  • Active Comparator: Placebo
    Standard arthroscopic debridement with fat pad harvest WITHOUT stem cell transplantation
    Intervention: Procedure: Arthroscopic debridement only
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 5, 2017)
99
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Michelle Backer (650) 721-7653 mbacker@stanford.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03014401
Other Study ID Numbers  ICMJE 36928
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jason L. Dragoo, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jason L Dragoo, MD Stanford University
PRS Account Stanford University
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP