Mesenchymal Stem Cell Augmentation in Patients Undergoing Arthroscopic Rotator Cuff Repair
Status: | Recruiting |
---|---|
Healthy: | No |
Age Range: | 18 - 70 |
Updated: | 10/27/2017 |
Start Date: | November 2015 |
End Date: | November 2020 |
Contact: | Kavita Ahuja, MBBS |
Email: | kavita.ahuja@rushortho.com |
Phone: | (312) 563-2214 |
A Prospective Randomized Trial of Biologic Augmentation With Mesenchymal Stem Cells in Patients Undergoing Arthroscopic Rotator Cuff Repair
The primary objective of this study is to compare the clinical outcomes of arthroscopic
rotator cuff repair with and without augmentation of mesenchymal stem cells (MSCs).
Mesenchymal stem cells promote tissue regeneration by differentiating into adult cell lines
and by supplying growth factors to their implanted environment. They have been shown to be
effective in improving both overall healing and tendon integrity in rotator cuff repair. This
study will follow 100 patients in the United States and track their clinical outcomes for at
least one year post-operatively.
rotator cuff repair with and without augmentation of mesenchymal stem cells (MSCs).
Mesenchymal stem cells promote tissue regeneration by differentiating into adult cell lines
and by supplying growth factors to their implanted environment. They have been shown to be
effective in improving both overall healing and tendon integrity in rotator cuff repair. This
study will follow 100 patients in the United States and track their clinical outcomes for at
least one year post-operatively.
Rotator cuff repair is one of the most commonly performed arthroscopic procedures in the
United States, but re-tear remains a common long-term complication. This can lead to pain,
decreased shoulder function, and the need for corrective surgery. Mesenchymal stem cells have
been shown to improve healing rates in arthroscopic rotator cuff repair, primarily due to
their retained ability to differentiate into several different adult cell lines, such as
tenocytes, chondrocytes, and osteoblasts. MSCs further enhance the healing process by
releasing growth factors into the local environment to promote tissue regeneration.
While MSC augmentation of arthroscopic rotator cuff repair has led to higher rates of healing
and improved tendon integrity, there remains a paucity of data surrounding clinical
improvement after the procedure. Outcomes such as post-operative strength, range of motion,
and shoulder function have yet to be compared with standard rotator cuff repair. The
incidence of post-operative persistent structural defects in the tendon after MSC
augmentation must also be further elucidated.
United States, but re-tear remains a common long-term complication. This can lead to pain,
decreased shoulder function, and the need for corrective surgery. Mesenchymal stem cells have
been shown to improve healing rates in arthroscopic rotator cuff repair, primarily due to
their retained ability to differentiate into several different adult cell lines, such as
tenocytes, chondrocytes, and osteoblasts. MSCs further enhance the healing process by
releasing growth factors into the local environment to promote tissue regeneration.
While MSC augmentation of arthroscopic rotator cuff repair has led to higher rates of healing
and improved tendon integrity, there remains a paucity of data surrounding clinical
improvement after the procedure. Outcomes such as post-operative strength, range of motion,
and shoulder function have yet to be compared with standard rotator cuff repair. The
incidence of post-operative persistent structural defects in the tendon after MSC
augmentation must also be further elucidated.
Inclusion Criteria:
- Patient is determined to have a full thickness rotator cuff tear (1-3 cm) or partial
tear converted to a full-thickness tear-on the pre-operative MRI scan or found
arthroscopically—and is scheduled to undergo surgical repair
- Written informed consent is obtained
Exclusion Criteria:
- Revision surgery
- Irreparable tear or partial repair
- Any patient lacking decisional capability
- Subscapularis involvement
We found this trial at
1
site
1653 W. Congress Parkway
Chicago, Illinois 60612
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Nikhil N Verma, MD
Phone: 312-563-2883
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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