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Safety and Efficacy of Adult Adipose-Derived Stem Cell Injection Into 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: NCT04077190
Recruitment Status : Enrolling by invitation
First Posted : September 4, 2019
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
InGeneron, Inc.

Brief Summary:
Extension Study of Protocol RC-001- Safety and Efficacy of Adult Adipose-Derived Stem Cell Injection into Partial Thickness Rotator Cuff Tears. Purpose is to investigate the Long- term safety and efficacy of autologous stem cells in patients with partial thickness rotator cuff tears versus a steroid treatment.

Condition or disease Intervention/treatment Phase
Rotator Cuff Tears Device: Adipose-derived stem cells Device: cortisone injection Not Applicable

Detailed Description:

The purpose of this investigation is to evaluate the safety and superior effectiveness in functional improvement in patients with partial-thickness rotator cuff tears (PTRCTs) after the administration of a single injection of adipose-derived regenerative cells (ADRCs) into the partial-thickness rotator cuff tear compared to the administration of a single corticosteroid injection into the associated subacromial space.

The ADRC mixture is generated from the Transpose® RT System, a point-of-care solution for extraction of an autologous regenerative cell mixture from the adipose tissue after a same-day limited liposuction procedure. A pilot clinical study was recently completed using an injection of ADRC compared to a corticosteroid injection for treatment of PTRCTs. Results support the initiation of a pivotal study to study the same.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Extension Study of Protocol RC-001b- Safety and Efficacy of Adult Adipose-Derived Stem Cell Injection Into Partial Thickness Rotator Cuff Tears
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : September 1, 2020

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 adipose derived stem cells
Device: Adipose-derived stem cells
5cc adipose derived stem cells.

Active Comparator: cortisone injection
Ultrasound guided injection of cortisone
Device: cortisone injection
cortisone injection




Primary Outcome Measures :
  1. Long term Safety as indicated through adverse event rate between ADSC and TAU arms [ Time Frame: at 24 months ]
    Adverse event rate

  2. Long term Safety as indicated through adverse event rate between ADSC and TAU arms [ Time Frame: at 36 months ]
    Adverse event rate

  3. Long term efficacy of pain and function through Short Form-36 Shoulder Score health questionnaires [ Time Frame: at 24 months ]
    Short form-36 score compared to baseline (total score = 800)

  4. Long term efficacy of pain and function through Short Form-36 Shoulder Score health questionnaires [ Time Frame: at 36 months ]
    Short form-36 score compared to baseline (total score = 800)

  5. Long term efficacy of pain and function through ASES Shoulder Score health questionnaires [ Time Frame: at 24 months ]
    ASES score compared to baseline (total score = 100)

  6. Long term efficacy of pain and function through ASES Shoulder Score health questionnaires [ Time Frame: at 36 months ]
    ASES score compared to baseline (total score = 100)


Secondary Outcome Measures :
  1. Long term efficacy will be evaluated through MRIs pre- and post-injection for the therapeutic intent to treat a rotator cuff injury: Percentage improvement in tendon tear size and thickness [ Time Frame: at 36 months ]
    Percentage improvement in tendon tear size and thickness



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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patient completed participation in RC-001 (NCT02918136) study
  • Must have the ability to understand and sign a written informed consent form (ICF), which must be obtained prior to initiation of study procedures associated with this trial.

Exclusion Criteria:

  • none

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): NCT04077190


Locations
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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.
Investigators
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Principal Investigator: jason Hurd, MD Sanford Orthopedics & Sports Medicine

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Responsible Party: InGeneron, Inc.
ClinicalTrials.gov Identifier: NCT04077190     History of Changes
Other Study ID Numbers: RC-003
First Posted: September 4, 2019    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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: No
Pediatric Postmarket Surveillance of a Device Product: No
Additional relevant MeSH terms:
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Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries
Cortisone
Anti-Inflammatory Agents