Mesenchymal Stem Cell Augmentation in Patients Undergoing Arthroscopic Rotator Cuff Repair

NCT02484950 | Completed Results

• 1 other identifier: 15042702
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Full Thickness Rotator Cuff Tear

Keywords

Mesenchymal stem cells

Outcome Measures

Primary Outcomes (1)

• American Shoulder and Elbow Surgeons (ASES) Score

  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

  One year

Study Arms (2)

Rotator cuff repair with stem cells

EXPERIMENTAL

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; Procedure: Standard arthroscopic rotator cuff repair

Rotator cuff repair without stem cells

PLACEBO COMPARATOR

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

Interventions

Mesenchymal stem cell augmentation in rotator cuff repair BIOLOGICAL

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.

Rotator cuff repair with stem cells

Standard arthroscopic rotator cuff repair PROCEDURE

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.

Rotator cuff repair with stem cells; Rotator cuff repair without stem cells

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Revision surgery
• Irreparable tear or partial repair
• Any patient lacking decisional capability
• Subscapularis involvement

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (4)

• 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.

  PMID: 22048089 BACKGROUND

• 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.

  PMID: 19405008 BACKGROUND

• 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.

  PMID: 20124055 BACKGROUND

• Cole BJ, Kaiser JT, Wagner KR, Sivasundaram L, Otte RS, Tauro TM, White GM, Ralls ML, Yanke AB, Forsythe B, Romeo AA, Verma NN. Prospective Randomized Trial of Biologic Augmentation With Bone Marrow Aspirate Concentrate in Patients Undergoing Arthroscopic Rotator Cuff Repair. Am J Sports Med. 2023 Apr;51(5):1234-1242. doi: 10.1177/03635465231154601. Epub 2023 Feb 22.

  PMID: 36811557 DERIVED

Results Point of Contact

• Title: Brian Cole
• Organization: Rush University Medical Center

Brian.cole@rushortho.com

(312) 432-2818

Study Officials

• Nikhil N Verma, MD

  Midwest Orthopaedics at Rush University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2015
• First Posted: June 30, 2015
• Study Start: November 15, 2015
• Primary Completion: May 1, 2024
• Study Completion: June 27, 2024
• Last Updated: July 28, 2025
• Results First Posted: March 6, 2025

Record last verified: 2025-07

Locations

US (1)