Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Bone Marrow Derived Stem Cells for the Treatment of Rotator Cuff Tears

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: NCT03688308
Recruitment Status : Recruiting
First Posted : September 28, 2018
Last Update Posted : March 29, 2019
Sponsor:
Information provided by (Responsible Party):
Jason L. Dragoo, Stanford University

Tracking Information
First Submitted Date  ICMJE September 21, 2018
First Posted Date  ICMJE September 28, 2018
Last Update Posted Date March 29, 2019
Actual Study Start Date  ICMJE March 27, 2019
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 26, 2018)
Tendon healing rates [ Time Frame: 24 months ]
Percent of rotator cuff repairs that demonstrate full healing at 2 years post surgery
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2018)
  • UCLA Score [ Time Frame: Date of enrollment to 24 months post-operatively ]
    UCLA score (0-35 points; higher score is better) at 24 months post surgery to measure functional outcome.
  • ASES Score [ Time Frame: Date of enrollment to 24 months post-operatively ]
    American Shoulder and Elbow Surgeons Shoulder Score (ASES) (0-100 points; higher score is better) at 24 months to measure functional outcome.
  • Constant Score [ Time Frame: Date of enrollment to 24 months post-operatively ]
    Constant score (0-100 points; higher score is better) at 24 months.
  • Retention of the mesenchymal stem cells [ Time Frame: 7 days ]
    Imaging of labeled mesenchymal stems cells in the shoulder to assess retention post injection
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 Bone Marrow Derived Stem Cells for the Treatment of Rotator Cuff Tears
Official Title  ICMJE Randomized Control Trial of Bone Marrow Derived Stem Cells Combined With Arthroscopic Surgery Versus Arthroscopic Surgery Only for the Treatment of Rotator Cuff Tears
Brief Summary The primary objective is to determine whether adjunct treatment using bone marrow aspirate concentrate (BMAC) in conjunction with arthroscopic repair of rotator cuff tears reduces retear rates compared to a control population undergoing arthroscopic repair without BMAC administration. The secondary objectives are to (1) evaluate the survival and incorporation of BMAC labeled cells with MRI imaging using the Ferumoxytol infusion stem cell labeling technique, and (2) determine if administration of BMAC leads to better clinical outcomes as measured by ASES, UCLA and Constant scoring metrics.
Detailed Description

Rotator cuff repair and regeneration has become a focal point for scientists and surgeons in search for a biological treatment to improve tendon healing, especially in situations of unfavorable biological conditions. Recent literature supports harvesting and centrifuging bone marrow aspirate to produce bone marrow aspirate concentration (BMAC) in hopes that mesenchymal stem cells in the bone marrow aspirate can promote tendon healing and regeneration.

This is a single blinded randomized clinical trial using labeled BMAC cells in adults diagnosed with medium to large, single tears of the rotator cuff. This is a single site study where at least 45 cases among eligible patients will be identified and randomly assigned to a either a control (arthroscopic repair without BMAC) group or experimental (arthroscopic repair with BMAC) group. A power analysis will be performed after enrolling 20 patients to determine the total number of patients required to reach adequate power.

A patient will receive an infusion of Ferumoxytol 1 day prior to the surgical procedure. An infusion nurse will be present at all times during the infusion to monitor vitals. On the day of the surgical procedure patients in the both groups will undergo arthroscopic rotator cuff repair using a double-row technique. Patients in the experimental group will also undergo harvesting of bone marrow aspirate from the anterior inferior iliac crest, which will be centrifuged to about 3-4cc of BMAC and placed beneath the tendon at the bone interface. MRIs will be completed on days 1 and 7 post-operatively to track retention of the labeled mesenchymal cells. Ultrasound imaging will be performed at 6 months post-surgery to evaluate tendon healing. Final MRIs will be obtained at 1 year and 2 years post surgery. Patient related outcomes will be collected at the pre-operative visit, 3 months, 6 months, 1 year and 2 years post surgery in the forms of ASES, UCLA and Constant scoring.

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 includes BMAC administration
Primary Purpose: Treatment
Condition  ICMJE
  • Rotator Cuff Tear
  • Rotator Cuff Injury
Intervention  ICMJE
  • Procedure: Arthroscopic rotator cuff repair with bone marrow aspirate concentrate
    Subjects will undergo shoulder arthroscopy for rotator cuff repair using a double row technique. Subjects will also be injected with bone marrow aspirate concentrate harvested from the pelvis and centrifuged prior to injection in the shoulder (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)
  • Procedure: Arthroscopic rotator cuff repair
    Subjects will undergo shoulder arthroscopy for rotator cuff repair using a double row technique.
Study Arms  ICMJE
  • Experimental: Shoulder arthroscopy with BMAC
    This arm will have patients who receive surgical intervention with arthroscopic rotator cuff repair along with 3-4cc of BMAC produced from the Harvest/Terumo BCT system
    Intervention: Procedure: Arthroscopic rotator cuff repair with bone marrow aspirate concentrate
  • Active Comparator: Shoulder arthroscopy alone
    This arm will have patients who receive surgical intervention with arthroscopic rotator cuff repair without administration of BMAC.
    Intervention: Procedure: Arthroscopic rotator cuff repair
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: September 26, 2018)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2021
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adults aged 50-75 patients with MRI confirmed rotator cuff tears sized 1.5-3cm including supraspinatus with or without an associated partial infraspinatus or subscapularis tear
  • Chronic tear > 3 months
  • Failed a minimum of 6 weeks of physical therapy
  • Hamada stage 1
  • Goutallier staging < 3

Exclusion Criteria:

  • Radiographs demonstrating mild to moderate arthritis
  • Diagnosis of Inflammatory (RA, JIA etc) or infectious arthritis
  • Hamada stage > 2
  • Cortisone and/or Hyaluronic acid intra-articular injection within the last 3 months
  • Brachial plexus pathology
  • Currently pregnant or planning to become pregnant
  • Shoulder PRP injection within the last year
  • History of iron overload syndrome
  • Concurrent surgery for shoulder instability
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Anna Ramakrishnan (650) 497-3597 annarama@stanford.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03688308
Other Study ID Numbers  ICMJE IRB-47762
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: No
Responsible Party Jason L. Dragoo, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jason L Dragoo 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