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Safety and Efficacy Adipose-Derived Stem Cell Injection Partial Thickness Rotator Cuff Tears

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ClinicalTrials.gov Identifier: NCT02918136
Recruitment Status : Completed
First Posted : September 28, 2016
Last Update Posted : February 11, 2021
Information provided by (Responsible Party):
InGeneron, Inc.

Brief Summary:

This is a prospective, randomized, multi-site, safety and efficacy study in subjects with rotator cuff injuries.

Patients will fall into two categories: treatment group (12 subjects) and non-treatment or control group (six subjects). The treatment group will undergo a small liposuction procedure and receive rotator cuff repair treatment with an ultrasound-guided injection of 5cc adipose-derived stem cells (ADSCs) into the point of injury. The control group will receive a 5cc cortisone injection into the point of injury

Condition or disease Intervention/treatment Phase
Rotator Cuff Tear - Partial Thickness Biological: Adipose derived regenerative cells Drug: Cortisone Injectable Not Applicable

Detailed Description:

The primary objectives of this study were to evaluate the safety of adult Adipose-Derived Stem Cell (ADRC) injection into partial thickness rotator cuff tears as indicated through adverse event rate and efficacy of pain and function through Rand short form-36 questionnaire and ASES Shoulder Score health questionnaires.

The secondary objective of this study was to assess the efficacy of adult ADRC injection into partial thickness rotator cuff tears through MRIs pre-and post-injection for the therapeutics intent to treat a rotator cuff injury.

Patients enrolled on this study received either ADRC (i.e., investigational treatment group) or TAU (i.e., control group). The investigational treatment group underwent a small liposuction procedure and received rotator cuff repair treatment with an ultrasound-guided injection of 5cc ADRCs into the point of injury. The control group received a 5cc cortisone injection. All patients, regardless of treatment, were followed up as indicated on the schedule of events table in the clinical study protocol.

Two clinical trial sites (Sioux Falls, SD and Fargo ND) enrolled subjects in this study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Adult Adipose-Derived Stem Cell Injections Into Partial Thickness Rotator Cuff Tears
Study Start Date : December 2016
Actual Primary Completion Date : July 31, 2018
Actual Study Completion Date : December 13, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arm Intervention/treatment
Experimental: adipose-derived stem cell injection
ultrasound guided injection of 5cc of adipose-derived stem cells (ADSCs)
Biological: Adipose derived regenerative cells
Other Name: ADRCs

Active Comparator: cortisone injection
ultrasound guided injection of cortisone
Drug: Cortisone Injectable
Other Name: steroid

Primary Outcome Measures :
  1. safety evaluation as indicated by collection of adverse events [ Time Frame: enrollment through 12months of follow-up ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Males and females 30-75 years of age.
  2. Clinical symptoms consistent with a rotator cuff lesion including but not limited to pain, muscle weakness, or active-limited range of motion (AROM).
  3. Subjects who have not responded to physical therapy treatments for at least six weeks.
  4. Subjects with > 70% passive range of motion (PROM).
  5. Diagnosed with >50% tear to supraspinatus muscle or < 5mm separation assessed by MRI.
  6. Diagnosed with a partial-thickness rotator cuff tear
  7. The ability of subjects to give appropriate consent or have an appropriate representative available.

Exclusion Criteria:

  1. Age <30 or > 75
  2. Insufficient amount of subcutaneous tissue to allow recovery of 50cc of lipoaspirate.
  3. History of systemic malignant neoplasms within last 5 years.
  4. History of local neoplasm within the last 6 months and any history of local neoplasm at site of administration.
  5. Subject is receiving immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.).
  6. Subjects who are known to be HIV positive
  7. Patients who have received a corticosteroid injection in rotator cuff site within last 3 months
  8. Severe arthrosis of the glenohumeral or acromioclavicular joint
  9. Irreparable rotator cuff tear (including rotator cuff tear arthropathy)
  10. Fatty atrophy above Grade 2 in affected shoulder
  11. Previous shoulder surgeries in affected shoulder
  12. History of tobacco use within the last 3 months
  13. Any contraindications to MRI scan according to MRI guidelines, or unwillingness to undergo MRI procedures
  14. Patients on an active regimen of chemotherapy
  15. Patients with a documented history of liver disease or an ALT value >400
  16. Allergy to sodium citrate of any "caine" type of local anesthetic
  17. Patients pregnant or breast feeding
  18. Subject is in the opinion of the Investigator or designee, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason. This includes completion of Patient Reported Outcome instruments.
  19. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
  20. Subject is part of a vulnerable population who, in the judgment of the investigator, is unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include: Individuals with mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention.
  21. Uncooperative patients or those with neurological/psychiatric disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations.

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): NCT02918136

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United States, North Dakota
Sanford Orthopedics and Sports Medicine - Fargo
Fargo, North Dakota, United States, 58103
United States, South Dakota
Sanford orthopedics and Sports Medicine - Sioux Falls
Sioux Falls, South Dakota, United States, 57104
Sponsors and Collaborators
InGeneron, Inc.
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Principal Investigator: Jason Hurd, M.D. Sanford Orthopedics & Sports Medicine - Sioux Falls, SD
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: InGeneron, Inc.
ClinicalTrials.gov Identifier: NCT02918136    
Other Study ID Numbers: RTC-001
First Posted: September 28, 2016    Key Record Dates
Last Update Posted: February 11, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Rotator Cuff Injuries
Wounds and Injuries
Shoulder Injuries
Tendon Injuries
Anti-Inflammatory Agents