Stromal Vascular Fraction Cell Therapy to Improve the Repair of Rotator Cuff Tears

January 17, 2024 updated by: Hospital for Special Surgery, New York

A Phase II Study to Evaluate Autologous Stromal Vascular Fraction Cell Therapy to Improve the Repair of Chronically Rotator Cuff Tears

Rotator cuff disease is one of the most prevalent musculoskeletal conditions across the world. Patients with chronic rotator cuff tears often have substantial muscle atrophy and fatty infiltration. Surgical repair of the tear does not reverse the atrophy, and many patients continue to experience weakness, pain, and a persistent reduction in the quality of life. An important limitation in our ability to successfully rehabilitate these injuries postoperatively and return patients to normal function has to do with the poor quality of the muscle and tendon after rotator cuff repair. The stromal vascular fraction (SVF) of subcutaneous adipose tissue is highly enriched with cells (SVFCs) that can both directly participate in tissue regeneration by differentiating into myogenic and tenogenic cells, and indirectly by secreting growth factors and small molecules which activate pathways associated with healthy tissue regeneration. High numbers of autologous SVFCs can be isolated using the cost-effective, intraoperative Icellator (Tissue Genesis, Honolulu, HI) point-of-care system. This clinical trial will be determine if the use of SVFCs can enhance outcomes for patients who are undergoing surgical repair of a torn supraspinatus rotator cuff.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

56

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Hospital for Special Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Males and females
  • Age 45-65 years old at the time of enrollment
  • Full-thickness supraspinatus tendon tear with endon retraction ≤ 3 cm
  • Magnetic resonance imaging Goutallier score ≤ grade 2
  • Completed at least 6 weeks of standard physical therapy but continue to have pain and limited function (failed physical therapy)
  • Sufficient subcutaneous abdominal adipose tissue to allow the recovery of 60-120cc of lipoaspirate
  • Must pass standard of care blood work screening

Exclusion Criteria:

  • Any tears of any cuff tendon other than the supraspinatus
  • Magnetic resonance imaging Goutallier scores ≥ 3
  • Frank signs of glenohumeral osteoarthritis on magnetic resonance imaging
  • A history of previous rotator cuff repair
  • A history of upper extremity fracture or other moderate to severe upper extremity trauma
  • A BMI < 20 or > 35
  • Pregnant or breast feeding
  • Premenopausal women who are not using contraception
  • Previous abdominal liposuction or any major open abdominal surgery
  • Type I or type II diabetes, or glycated hemoglobin (hemoglobin A1C) values > 6.5 or other metabolic disorders
  • Hypercholesterolemia (total cholesterol ≥240mg/dL)
  • History of cancer
  • Autoimmune disorder or HIV+ status
  • Use of nicotine products
  • Have any other history of major medical illness, disease or other relevant orthopaedic disability
  • Who do not speak English
  • Liodcaine allergy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Patients will receive an injection of vehicle (Ringer's solution) into their supraspinatus muscle and tendon at the time of rotator cuff repair
Device: Ringer's solution
Ringer's solution
Active Comparator: Cell Therapy
Patients will receive an injection of stromal vascular fraction material suspended in vehicle (Ringer's solution) into their supraspinatus muscle and tendon at the time of rotator cuff repair
Device: Autologous Stomal Vascular Fraction Material
Autologous Stomal Vascular Fraction Material Prepared from the Tissue Genesis® Icellator Cell Isolation System™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in scapular plane abduction strength from baseline, and additional isometric, isokinetic strength measurements to assess supraspinatus function.
Time Frame: 2 weeks prior to surgery, 6 months after surgery, 12 months after surgery, 24 months after surgery
2 weeks prior to surgery, 6 months after surgery, 12 months after surgery, 24 months after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Penn Shoulder score, ASES score and Short Form Global Health scale (PROMIS-SF) from baseline (range 0 minimum to 30 maximum)
Time Frame: 2 weeks prior to surgery, 6 weeks after surgery, 6 months after surgery, 12 months after surgery, 24 months after surgery
2 weeks prior to surgery, 6 weeks after surgery, 6 months after surgery, 12 months after surgery, 24 months after surgery
Change in supraspinatus muscle stiffness from baseline, measured by ultrasound shear wave elastrography
Time Frame: 1 month prior to surgery, 6 months after surgery, 24 months after surgery
1 month prior to surgery, 6 months after surgery, 24 months after surgery
Change in fatty infiltration from baseline, measured by magnetic resonance imaging
Time Frame: 1 month prior to surgery, 6 months after surgery, 24 months after surgery
1 month prior to surgery, 6 months after surgery, 24 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital for Special Surgery, New York

Collaborators

Orthopedic Research and Education Foundation

Investigators

  • Principal Investigator: Scott Rodeo, MD, Hospital for Special Surgery, New York

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2019

Primary Completion (Estimated)

June 23, 2025

Study Completion (Estimated)

July 23, 2025

Study Registration Dates

First Submitted

October 30, 2017

First Submitted That Met QC Criteria

November 1, 2017

First Posted (Actual)

November 6, 2017

Study Record Updates

Last Update Posted (Actual)

January 18, 2024

Last Update Submitted That Met QC Criteria

January 17, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-0999

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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