Status:
COMPLETED
Safety and Efficacy of Adult Adipose-Derived Stem Cell Injection Into Partial Thickness Rotator Cuff Tears
Lead Sponsor:
InGeneron, Inc.
Conditions:
Rotator Cuff Tears
Eligibility:
All Genders
30-75 years
Phase:
NA
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 effi...
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...
Eligibility Criteria
Inclusion
- 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
- none
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04077190
Start Date
August 1 2019
End Date
December 1 2021
Last Update
August 3 2022
Active Locations (2)
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1
Sanford Orthopedics and Sports Medicine - Fargo
Fargo, North Dakota, United States, 58103
2
Sanford orthopedics and Sports Medicine - Sioux Falls
Sioux Falls, South Dakota, United States, 57104