- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04077190
Safety and Efficacy of Adult Adipose-Derived Stem Cell Injection Into Partial Thickness Rotator Cuff Tears
Extension Study of Protocol RC-001b- Safety and Efficacy of Adult Adipose-Derived Stem Cell Injection Into Partial Thickness Rotator Cuff Tears
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Dakota
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Fargo, North Dakota, United States, 58103
- Sanford Orthopedics and Sports Medicine - Fargo
-
-
South Dakota
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Sioux Falls, South Dakota, United States, 57104
- Sanford orthopedics and Sports Medicine - Sioux Falls
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: adipose-derived stem cell injection
Ultrasound guided injection of 5cc adipose derived stem cells
|
5cc adipose derived stem cells.
|
Active Comparator: cortisone injection
Ultrasound guided injection of cortisone
|
cortisone injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Long term Safety as indicated through adverse event rate between ADSC and TAU arms
Time Frame: at 24 months
|
Adverse event rate
|
at 24 months
|
Long term Safety as indicated through adverse event rate between ADSC and TAU arms
Time Frame: at 36 months
|
Adverse event rate
|
at 36 months
|
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)
|
at 24 months
|
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)
|
at 36 months
|
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)
|
at 24 months
|
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)
|
at 36 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
at 36 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: jason Hurd, MD, Sanford Orthopedics & Sports Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC-003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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-
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