Bone Marrow Derived Stem Cells for the Treatment of Rotator Cuff Tears
Withdrawn before enrolling · Not applicable
Conditions studied: Rotator Cuff Tear, Rotator Cuff Injury
In brief
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.
Key facts
- Study ID
- NCT03688308
- Run by
- Stanford University
- People needed
- 0
- Starts
- 2020-01-01
- Expected to finish
- 2021-10-01
- Last updated by the study team
- 2021-04-23
Who can join
Age: 50 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Stanford University — Redwood City, California, United States
Full record on ClinicalTrials.gov
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