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Trial record 29 of 138 for:    Recruiting, Not yet recruiting, Available Studies | "Lacerations"

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

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ClinicalTrials.gov Identifier: NCT03332238
Recruitment Status : Not yet recruiting
First Posted : November 6, 2017
Last Update Posted : March 19, 2018
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 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

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
Estimated Study Start Date : June 1, 2018
Estimated Primary Completion Date : December 31, 2021
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 [ 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 external rotation strength from baseline [ Time Frame: 2 weeks prior to surgery, 6 months after surgery, 12 months after surgery, 24 months after surgery ]
  2. Change in Penn Shoulder Score outcome involved score from baseline (range 0 minimum to 100 maximum) [ Time Frame: 2 weeks prior to surgery, 6 weeks after surgery, 6 months after surgery, 12 months after surgery, 24 months after surgery ]
  3. Change in Patient-Reported Outcomes Measurement Information System-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 ]
  4. Change in supraspinatus muscle stiffness from baseline, measured by ultrasound elastrography [ Time Frame: 1 month prior to surgery, 6 months after surgery, 24 months after surgery ]
  5. 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 ]


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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:

  • Both sexes
  • Age 45-65 years
  • Full-thickness supraspinatus tendon tear
  • Supraspinatus tendon retraction less than or equal to 3 cm
  • Magnetic resonance imaging Goutallier score less than or equal to grade 2

Exclusion Criteria:

  • Any torn rotator cuff tendon other than the supraspinatus
  • Magnetic resonance imaging Goutallier scores greater than or equal to 3
  • Frank signs of glenohumeral osteoarthritis on magnetic resonance imaging
  • History of previous rotator cuff repair
  • History of upper extremity fracture or other moderate to severe upper extremity trauma
  • BMI less than 20 or greater than 35
  • Previous history of abdominal liposuction or any major open abdominal surgery
  • Type I or type II diabetes mellitus, or other metabolic disorders
  • History of cancer
  • Autoimmune disorder or who are
  • HIV+
  • Active use of nicotine products
  • Any other history of major medical illness, disease or other relevant orthopaedic disability

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

Locations
United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
Hospital for Special Surgery, New York
Orthopedic Research and Education Foundation
Investigators
Principal Investigator: Christopher Mendias, PhD, ATC Hospital for Special Surgery, New York
Principal Investigator: Scott Rodeo, MD Hospital for Special Surgery, New York

Publications:

Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT03332238     History of Changes
Other Study ID Numbers: 2017-0999
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018

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
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
Atrophy
Rotator Cuff Injuries
Muscular Atrophy
Pathological Conditions, Anatomical
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Pharmaceutical Solutions