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

Trial ID or NCT#

NCT03688308

Status

not recruiting iconNOT RECRUITING

Purpose

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.

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

Eligibility Criteria

Ages Eligible for Study: 50 Years to 75 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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

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Contact

Anna Ramakrishnan
650-497-3597