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Trial record 12 of 1808 for:    "bone marrow" | Recruiting, Not yet recruiting Studies

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

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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

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.

Condition or disease Intervention/treatment Phase
Rotator Cuff Tear Rotator Cuff Injury Procedure: Arthroscopic rotator cuff repair with bone marrow aspirate concentrate Procedure: Arthroscopic rotator cuff repair Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
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
Official Title: Randomized Control Trial of Bone Marrow Derived Stem Cells Combined With Arthroscopic Surgery Versus Arthroscopic Surgery Only for the Treatment of Rotator Cuff Tears
Actual Study Start Date : March 27, 2019
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arm Intervention/treatment
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
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)

Active Comparator: Shoulder arthroscopy alone
This arm will have patients who receive surgical intervention with arthroscopic rotator cuff repair without administration of BMAC.
Procedure: Arthroscopic rotator cuff repair
Subjects will undergo shoulder arthroscopy for rotator cuff repair using a double row technique.




Primary Outcome Measures :
  1. Tendon healing rates [ Time Frame: 24 months ]
    Percent of rotator cuff repairs that demonstrate full healing at 2 years post surgery


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Constant Score [ Time Frame: Date of enrollment to 24 months post-operatively ]
    Constant score (0-100 points; higher score is better) at 24 months.

  4. Retention of the mesenchymal stem cells [ Time Frame: 7 days ]
    Imaging of labeled mesenchymal stems cells in the shoulder to assess retention post injection



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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): NCT03688308


Contacts
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Contact: Anna Ramakrishnan (650) 497-3597 annarama@stanford.edu

Locations
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United States, California
Stanford University Recruiting
Redwood City, California, United States, 94063
Contact: Anna Ramakrishnan    650-497-3597    annarama@stanford.edu   
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Jason L Dragoo Stanford University

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Responsible Party: Jason L. Dragoo, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT03688308     History of Changes
Other Study ID Numbers: IRB-47762
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jason L. Dragoo, Stanford University:
Bone marrow aspirate
Biologics

Additional relevant MeSH terms:
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Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries