Safety and Efficacy of Adult Adipose-Derived Stem Cell Injection Into Partial Thickness Rotator Cuff Tears
NCT ID: NCT04077190
Last Updated: 2022-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
15 participants
INTERVENTIONAL
2019-08-01
2021-12-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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adipose-derived stem cell injection
Ultrasound guided injection of 5cc adipose derived stem cells
Adipose-derived stem cells
5cc adipose derived stem cells.
cortisone injection
Ultrasound guided injection of cortisone
cortisone injection
cortisone injection
Interventions
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Adipose-derived stem cells
5cc adipose derived stem cells.
cortisone injection
cortisone injection
Eligibility Criteria
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Inclusion Criteria
* 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
30 Years
75 Years
ALL
Yes
Sponsors
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InGeneron, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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jason Hurd, MD
Role: PRINCIPAL_INVESTIGATOR
Sanford Orthopedics & Sports Medicine
Locations
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Sanford Orthopedics and Sports Medicine - Fargo
Fargo, North Dakota, United States
Sanford orthopedics and Sports Medicine - Sioux Falls
Sioux Falls, South Dakota, United States
Countries
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Other Identifiers
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RC-003
Identifier Type: -
Identifier Source: org_study_id
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