RECRUITING

The Effect of Adipose-Derived Stem Cells for Knee Osteoarthritis

Talk to us

Conditions

Knee Osteoarthritisstem cellknee painosteoarthritisarthritisADSCfat stem cell

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Effect of Adipose-Derived Stem Cells for Knee Osteoarthritis: A Randomized Controlled Trial

Quick Facts

Study Start:2016-05
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03014401

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:35 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age between 35 and 70 years-old
  2. * Patient is scheduled to undergo one or a combination of the following procedures:
  3. * Meniscal debridement or partial menisectomy
  4. * Meniscal repair that does not necessitate a different postoperative protocol from meniscal debridement or partial menisectomy
  5. * Removal of loose bodies
  6. * Chondroplasty
  7. * Synovectomy
  8. * Soft tissue releases for flexion or extension contracture.
  9. * Diagnosis of pre-existing mild to moderate osteoarthritis of the medial or lateral femoral condyle (Kellgren-Lawrence Grade 2 or 3)
  10. * \< 6 months of knee pain or \< 6 months of a significant exacerbation of existing knee pain
  11. * Physical examination findings consistent with the proposed surgical procedure.
  12. * 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
  1. * Age \< 35 or \> 70 years old
  2. * Radiographs demonstrating either no, little or severe osteoarthritis (Kellgren-Lawrence Grade 0, 1 or 4)
  3. * Previous injury or surgery to the infrapatellar fat pad (assessed by MRI)
  4. * Patient scheduled to undergo any concomitant surgical procedures with the exception of:
  5. * Meniscal debridement or partial menisectomy
  6. * Meniscal repair that does not necessitate a different postoperative protocol from meniscal debridement or partial menisectomy
  7. * Removal of loose bodies
  8. * Chondroplasty
  9. * Synovectomy
  10. * Soft tissue releases for flexion or extension contracture
  11. * Prior surgery on ipsilateral knee involving cartilage regeneration (microfracture, Autologous Chondrocyte Implantation, etc) or meniscal transplant/implant
  12. * Previous arthroscopy within 1 year
  13. * Subchondral edema

Contacts and Locations

Study Contact

Kaitlyn Whitney
CONTACT
(720) 872-4836
Inverness.clinicaltrials@cuanschutz.edu

Principal Investigator

Jason L Dragoo, MD
PRINCIPAL_INVESTIGATOR
University of Colorado - Anschutz Medical Campus
Seth L Sherman, MD
PRINCIPAL_INVESTIGATOR
Stanford University

Study Locations (Sites)

Kerlan Jobe Orthopedic Institute
Santa Monica, California, 90404
United States
Stanford University
Stanford, California, 94305
United States
UC Health Steadman Hawkins Clinic - Denver Inverness
Denver, Colorado, 80112
United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

  • Jason L Dragoo, MD, PRINCIPAL_INVESTIGATOR, University of Colorado - Anschutz Medical Campus
  • Seth L Sherman, MD, PRINCIPAL_INVESTIGATOR, Stanford University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-05
Study Completion Date2025-12

Study Record Updates

Study Start Date2016-05
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • stem cell
  • knee pain
  • osteoarthritis
  • arthritis
  • ADSC
  • fat stem cell

Additional Relevant MeSH Terms

  • Knee Osteoarthritis