Mesenchymal Stem Cell Augmentation in Patients Undergoing Arthroscopic Rotator Cuff Repair

• ClinicalTrials.gov Identifier: NCT02484950
• Recruitment Status: Recruiting
• First Posted: June 30, 2015
• Last Update Posted: June 27, 2022
• Sponsor: Rush University Medical Center
• Information provided by (Responsible Party): Rush University Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Full Thickness Rotator Cuff Tear	Biological: Mesenchymal stem cell augmentation in rotator cuff repair; Procedure: Standard arthroscopic rotator cuff repair	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Prospective Randomized Trial of Biologic Augmentation With Mesenchymal Stem Cells in Patients Undergoing Arthroscopic Rotator Cuff Repair
• Study Start Date: November 2015
• Estimated Primary Completion Date: November 2022
• Estimated Study Completion Date: March 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Rotator cuff repair with stem cells; 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.	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.
Placebo Comparator: Rotator cuff repair without stem cells; 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.	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.

Outcome Measures

Primary Outcome Measures :

1. American Shoulder and Elbow Surgeons (ASES) Score [ Time Frame: One year ]
   The primary outcome measure will be the ASES score at one year follow-up.

Secondary Outcome Measures :

1. Magnetic Resonance Imaging (MRI) Scan [ Time Frame: 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.
2. Functional Outcomes - Shoulder Exam [ Time Frame: 6 weeks, 6 months, and 1 year ]
   Includes strength and range of motion to determine a Rowe score.
3. Patient Centered Outcomes - Shoulder Survey [ Time Frame: 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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Carla Edwards, PhD; (312) 563-5735; carla_edwards@rush.edu

Locations

United States, Illinois

Rush University Medical Center; Recruiting

Chicago, Illinois, United States, 60612

Contact: Barb L Ramsey, RN 312-563-2883

Principal Investigator: Nikhil N Verma, MD

Sub-Investigator: Brian Forsythe, MD

Sub-Investigator: Anthony Romeo, MD

Sub-Investigator: Gregory Nicholson, MD

Sub-Investigator: Brian J Cole, MD

Sponsors and Collaborators

Rush University Medical Center

Investigators

• Principal Investigator: Nikhil N Verma, MD; Midwest Orthopaedics at Rush University

  Study Documents (Full-Text)

Documents provided by Rush University Medical Center:

Informed Consent Form  [PDF] May 12, 2021

More Information

Publications:

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.

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. Review.

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.

• Responsible Party: Rush University Medical Center
• ClinicalTrials.gov Identifier: NCT02484950
• Other Study ID Numbers: 15042702
• First Posted: June 30, 2015
• Last Update Posted: June 27, 2022
• Last Verified: June 2022

Keywords provided by Rush University Medical Center:

Mesenchymal stem cells

Additional relevant MeSH terms:

Rotator Cuff Injuries; Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries