Mesenchymal Stem Cell Augmentation in Patients Undergoing Arthroscopic Rotator Cuff Repair

Full Thickness Rotator Cuff Tear Clinical Trial

Official title:

A Prospective Randomized Trial of Biologic Augmentation With Mesenchymal Stem Cells in Patients Undergoing Arthroscopic Rotator Cuff Repair

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02484950
• Other study ID #: 15042702
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2015
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 107
• Est. completion date: December 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

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:

• Revision surgery

• Irreparable tear or partial repair

• Any patient lacking decisional capability

• Subscapularis involvement

Related Conditions & MeSH terms

• Full Thickness Rotator Cuff Tear
• Rotator Cuff Injuries

Intervention

Biological:
• Mesenchymal stem cell augmentation in rotator cuff repair
Patients undergoing mesenchymal stem cell augmentation will receive a total injection of 6 milliliters (mL). Of this, 3 mL will be injected in the tendon at the junction between bone and tendon, while 3 mL will be injected in the bone at the site of the surgical footprint.

Procedure:
• Standard arthroscopic rotator cuff repair
All patients will undergo full thickness rotator cuff repair using a double row, transosseous-equivalent (TOE) repair with anchor/suture technique. Acromioplasty will be performed in all patients. Alternate procedures such as biceps tenotomy/tenodesis and distal clavicle excision will be performed at the discretion of the surgeon and recorded.

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (3)

MacDonald P, McRae S, Leiter J, Mascarenhas R, Lapner P. Arthroscopic rotator cuff repair with and without acromioplasty in the treatment of full-thickness rotator cuff tears: a multicenter, randomized controlled trial. J Bone Joint Surg Am. 2011 Nov 2;93(21):1953-60. doi: 10.2106/JBJS.K.00488. — View Citation

Roy JS, MacDermid JC, Woodhouse LJ. Measuring shoulder function: a systematic review of four questionnaires. Arthritis Rheum. 2009 May 15;61(5):623-32. doi: 10.1002/art.24396. — View Citation

Tashjian RZ, Deloach J, Green A, Porucznik CA, Powell AP. Minimal clinically important differences in ASES and simple shoulder test scores after nonoperative treatment of rotator cuff disease. J Bone Joint Surg Am. 2010 Feb;92(2):296-303. doi: 10.2106/JBJS.H.01296. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	American Shoulder and Elbow Surgeons (ASES) Score	The primary outcome measure will be the ASES score at one year follow-up.	One year
Secondary	Magnetic Resonance Imaging (MRI) Scan	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.	1 year
Secondary	Functional Outcomes - Shoulder Exam	Includes strength and range of motion to determine a Rowe score.	6 weeks, 6 months, and 1 year
Secondary	Patient Centered Outcomes - Shoulder Survey	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).	6 weeks, 6 months, and 1 year