Mesenchymal Stem Cell Augmentation in Patients Undergoing Arthroscopic Rotator Cuff Repair

Not Applicable

Completed

Interventions: Biological: Mesenchymal stem cell augmentation in rotator cuff repair
Procedure: Standard arthroscopic rotator cuff repair

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Rotator cuff repair with stem cells	Mesenchymal stem cell augmentation in rotator cuff repair	Using clinically accepted methods, subjects will undergo bone marrow aspiration (from hip, proximal humerus or tibia) through a small incision prior to arthroscopy in the group undergoing MSC augmentation. They will then undergo arthroscopic full thickness rotator cuff repair using a double row, TOE anchor/suture technique with mesenchymal stem cell augmentation.
Rotator cuff repair with stem cells	Standard arthroscopic rotator cuff repair	Using clinically accepted methods, subjects will undergo bone marrow aspiration (from hip, proximal humerus or tibia) through a small incision prior to arthroscopy in the group undergoing MSC augmentation. They will then undergo arthroscopic full thickness rotator cuff repair using a double row, TOE anchor/suture technique with mesenchymal stem cell augmentation.
Rotator cuff repair without stem cells	Standard arthroscopic rotator cuff repair	Subjects will undergo arthroscopic full thickness rotator cuff repair using a double row, TOE anchor/suture technique, without augmentation of mesenchymal stem cells. To maintain patient blinding, all patients will receive a small incision around the site of expected bone marrow aspiration (hip, proximal humerus, or tibia), regardless of whether or not they receive bone marrow.

Primary Outcome Measures

Name	Time	Method
American Shoulder and Elbow Surgeons (ASES) Score	One year	The American Shoulder and Elbow Surgeons (ASES) score is a patient-reported score that measures shoulder pain, activity level and stability. The score ranges from 0 to 100, with higher scores indicating better shoulder function. Excellent: 90-100 points Good: 70-89 points Fair: 40-49 points Poor: Less than 39 points

Secondary Outcome Measures

Name	Time	Method
Functional Outcomes - Shoulder Exam	6 weeks, 6 months, and 1 year	Includes strength and range of motion to determine a Rowe score.
Patient Centered Outcomes - Shoulder Survey	6 weeks, 6 months, and 1 year	Patients will be administered validated patient reported outcome measures post-operatively. These include a Visual Analog Scale (VAS) pain score, Constant score, Simple Shoulder Test, Single Assessment Numeric Evaluation (SANE) score, and the 12-Item Short Form Health Survey (SF-12).
Magnetic Resonance Imaging (MRI) Scan	1 year	To assess for persistent structural tendon defects and to determine the integrity of the repair with comparisons to pre-operative MRI anatomy and tear description at the time of surgery.