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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03332238
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : August 9, 2019
Sponsor:
Collaborator:
Orthopedic Research and Education Foundation
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Rotator Cuff Tear Muscle Atrophy Tendon Tear Device: Autologous Stomal Vascular Fraction Material Device: Ringer's solution Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II Study to Evaluate Autologous Stromal Vascular Fraction Cell Therapy to Improve the Repair of Chronically Rotator Cuff Tears
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

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™




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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. 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 ]
  3. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03332238


Contacts
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Contact: Daniel Edon, MS, CSCS 212-774-7833 EdonD@hss.edu

Locations
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United States, New York
Hospital for Special Surgery Recruiting
New York, New York, United States, 10021
Contact: Daniel Edon, MS, CSCS    212-774-7833    EdonD@hss.edu   
Contact: Bridget Hayes, MS    212-774-7154    Hayesb@hss.edu   
Principal Investigator: Christopher L Mendias, PhD, ATC         
Sponsors and Collaborators
Hospital for Special Surgery, New York
Orthopedic Research and Education Foundation
Investigators
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Principal Investigator: Christopher Mendias, PhD, ATC Hospital for Special Surgery, New York
Principal Investigator: Scott Rodeo, MD Hospital for Special Surgery, New York
Publications:

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Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT03332238    
Other Study ID Numbers: 2017-0999
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Muscular Atrophy
Atrophy
Rotator Cuff Injuries
Pathological Conditions, Anatomical
Wounds and Injuries
Rupture
Shoulder Injuries
Tendon Injuries
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms