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Use of MRI Labeling Technique to Track Mesenchymal Stem Cell Survival in Orthopaedic Conditions

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ClinicalTrials.gov Identifier: NCT03648463
Recruitment Status : Not yet recruiting
First Posted : August 27, 2018
Last Update Posted : March 28, 2019
Sponsor:
Information provided by (Responsible Party):
Jason L. Dragoo, Stanford University

Tracking Information
First Submitted Date  ICMJE August 22, 2018
First Posted Date  ICMJE August 27, 2018
Last Update Posted Date March 28, 2019
Estimated Study Start Date  ICMJE October 1, 2019
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 24, 2018)
Integration of the mesenchymal stem cells. [ Time Frame: 3 months ]
Number of integrated labeled mesenchymal stem cells in the cartilage regenerate counted from from MRI imaging.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03648463 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 24, 2018)
Knee Injury and Osteoarthritis Outcome Score (pain subscale) [ Time Frame: 12 months ]
KOOS pain score at baseline and at 12 months to measure functional outcomes. This sub scale of the KOOS questionnaire has a possible total of 100 points (higher scores mean less pain)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of MRI Labeling Technique to Track Mesenchymal Stem Cell Survival in Orthopaedic Conditions
Official Title  ICMJE Effect of Surgical Intervention on Mesenchymal Stem Cell Survival in Soft Tissue Reconstructive Procedures Using a Novel MRI Labeling Technique
Brief Summary

The primary objective is to determine whether a surgical intervention involving removing of the calcified cartilage cap in patients with Grade II Kellgren-Lawrence osteoarthritis influences the incorporation of labeled bone marrow aspirate concentrate (BMAC)-derived cells within the cartilage regenerate vs labeled BMAC cells delivered after arthroscopy without removing of the calcified cartilaginous layer. The survival and incorporation of the BMAC labeled cells will be evaluated with MRI using the Ferumoxytol infusion stem cell labeling technique. The second arm of the study evaluating cell fate after injecting stem cells under a rotator cuff repair will also be explored.

The secondary objectives are to 1) determine which surgical intervention leads to better clinical outcomes as measured by Knee Injury and Osteoarthritis Outcome Score (KOOS) at 12 months, and 2) determine who long we can track the labeled-BMAC cells in the knee.

Detailed Description

Articular cartilage repair and regeneration has become a focal point for scientists and surgeons in search for a biological treatment for osteoarthritis that has failed non-operative management. Surgeons have begun to harvest and centrifuged bone marrow aspirate to produce bone marrow aspirate concentrate (BMAC) in hopes that the mesenchymal stem cells in the bone marrow aspirate can stimulate cartilage regeneration in areas of articular cartilage deficiency. This study is a first-in-human blinded randomized clinical trial using labeled BMAC cells in adults diagnosed with grade II-III Kellgren-Lawrence osteoarthritis.

This is a single site study where 20 cases among eligible patients will be identified and randomly assigned to either the control (no calcified cartilage) or experimental (calcified cartilage removed) group. A power analysis will be performed after 20 patients to determine the total number of patients required to reach adequate power.

A patient will receive an infusion of Feraheme 2 days before the procedure and a baseline MR Pelvis and knee. A nurse will be present at all times during the infusion to monitor vitals. On the day of the procedure patient will undergo harvesting of the bone marrow from the pelvis and arthroscopy procedure involving menisectomy, synovectomy and debridement. Patients in the experimental group will also undergo removal of the calcified cartilage cap. The bone marrow aspirate will be centrifuged and about 5-7 cc of BMAC injected into knee. MRIs will be done at the 2 day mark for confirmation of the labeling of the mesenchymal cells, and at the two week and 3 month mark. Patient related Outcomes will be measured using the Knee injury and Osteoarthritis Score at 12 months follow up.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description:
Patients will not know if they received the surgical intervention that entails removing of the calcified cartilage or not.
Primary Purpose: Treatment
Condition  ICMJE
  • Cartilage Degeneration
  • Rotator Cuff Tear
  • Osteoarthritis, Knee
Intervention  ICMJE Procedure: arthroscopy of the affected knee/ Bone Marrow Concentrate Injection
Subjects will undergo knee arthroscopy for debridement, menisectomy and synovectomy of the cartilage defects. Subjects will also be injected with bone marrow aspirate concentrated harvested from the pelvis and centrifuged (produced produced using the Harvest/Terumo BCT system)
Other Name: Injection of bone marrow aspirate concentrate harvested from the patient's iliac crest (produced using the Harvest/Terumo BCT system)
Study Arms  ICMJE
  • Experimental: arthroscopy with removal of calcified cartilage
    This arm will have patients who will get surgical intervention (menisectomy, synovectomy and debridement) along with removal of the calcified cartilage layer. The patients will also get 5 cc of BMAC produced from The Harvest/Terumo BCT system.
    Intervention: Procedure: arthroscopy of the affected knee/ Bone Marrow Concentrate Injection
  • Active Comparator: arthroscopy without removal of calcified cartilage
    This arm will have patients who will get surgical intervention (menisectomy, synovectomy and debridement) but with retention of the calcified cartilage cap. The patients will also get 5 cc of BMAC produced from The Harvest/Terumo BCT system.
    Intervention: Procedure: arthroscopy of the affected knee/ Bone Marrow Concentrate Injection
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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 24, 2018)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Adults aged 30-70 patients with Kellgren grade II-III osteoarthritis,
  2. Symptomatic knee pain greater than 6 months
  3. At least one discrete contained chondral defect
  4. Failed a minimum of 6 weeks of physical therapy
  5. Grossly normal knee alignment: <5 degrees of varus or valgus alignment
  6. Lesion located on medial or lateral femoral condyle or trochlea

Exclusion Criteria:

  1. Radiographs demonstrating either no or little osteoarthritis (Kellgren-Lawrence Grade 0 or 1)
  2. Diagnosis of Inflammatory (RA, JIA etc) or infectious arthritis
  3. Malalignment of mechanical axis > or = 5 degrees of varus/valgus
  4. Cortisone and/or Hyaluronic acid intra-articular injection within the last 3 months
  5. Ligamentous knee instability
  6. The subject is on ongoing specific osteoarthritis drugs such as chondroitin sulphate, diacerein, N-glucosamine, piascledine, capsaicin in the 2 weeks prior to baseline treatment
  7. BMI > 30
  8. Currently pregnant or planning to become pregnant (no MRI possible).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03648463
Other Study ID Numbers  ICMJE IRB-46711
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
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 March 2019

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