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Safety and Efficacy Adipose-Derived Stem Cell Injection Partial Thickness 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02918136
Recruitment Status : Completed
First Posted : September 28, 2016
Last Update Posted : February 11, 2021
Sponsor:
Information provided by (Responsible Party):
InGeneron, Inc.

Tracking Information
First Submitted Date  ICMJE September 26, 2016
First Posted Date  ICMJE September 28, 2016
Last Update Posted Date February 11, 2021
Study Start Date  ICMJE December 2016
Actual Primary Completion Date July 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 26, 2016)
safety evaluation as indicated by collection of adverse events [ Time Frame: enrollment through 12months of follow-up ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Adipose-Derived Stem Cell Injection Partial Thickness Rotator Cuff Tears
Official Title  ICMJE Safety and Efficacy of Adult Adipose-Derived Stem Cell Injections Into Partial Thickness Rotator Cuff Tears
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

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Rotator Cuff Tear - Partial Thickness
Intervention  ICMJE
  • Biological: Adipose derived regenerative cells
    Other Name: ADRCs
  • Drug: Cortisone Injectable
    Other Name: steroid
Study Arms  ICMJE
  • Experimental: adipose-derived stem cell injection
    ultrasound guided injection of 5cc of adipose-derived stem cells (ADSCs)
    Intervention: Biological: Adipose derived regenerative cells
  • Active Comparator: cortisone injection
    ultrasound guided injection of cortisone
    Intervention: Drug: Cortisone Injectable
Publications * Hurd JL, Facile TR, Weiss J, Hayes M, Hayes M, Furia JP, Maffulli N, Winnier GE, Alt C, Schmitz C, Alt EU, Lundeen M. Safety and efficacy of treating symptomatic, partial-thickness rotator cuff tears with fresh, uncultured, unmodified, autologous adipose-derived regenerative cells (UA-ADRCs) isolated at the point of care: a prospective, randomized, controlled first-in-human pilot study. J Orthop Surg Res. 2020 Mar 30;15(1):122. doi: 10.1186/s13018-020-01631-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 26, 2016)
18
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 13, 2018
Actual Primary Completion Date July 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02918136
Other Study ID Numbers  ICMJE RTC-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party InGeneron, Inc.
Study Sponsor  ICMJE InGeneron, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jason Hurd, M.D. Sanford Orthopedics & Sports Medicine - Sioux Falls, SD
PRS Account InGeneron, Inc.
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP