Back to resultsSafety and Efficacy of Adult Adipose-Derived Stem Cell Injection Into Partial Thickness Rotator Cuff Tears
Primary Purpose
Rotator Cuff Tears
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Adipose-derived stem cells
cortisone injection
Sponsored by
About this trial
This is an interventional treatment trial for Rotator Cuff Tears
Eligibility 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
Sites / Locations
- Sanford Orthopedics and Sports Medicine - Fargo
- Sanford orthopedics and Sports Medicine - Sioux Falls
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
adipose-derived stem cell injection
cortisone injection
Arm Description
Ultrasound guided injection of 5cc adipose derived stem cells
Ultrasound guided injection of cortisone
Outcomes
Primary Outcome Measures
Long term Safety as indicated through adverse event rate between ADSC and TAU arms
Adverse event rate
Long term Safety as indicated through adverse event rate between ADSC and TAU arms
Adverse event rate
Long term efficacy of pain and function through Short Form-36 Shoulder Score health questionnaires
Short form-36 score compared to baseline (total score = 800)
Long term efficacy of pain and function through Short Form-36 Shoulder Score health questionnaires
Short form-36 score compared to baseline (total score = 800)
Long term efficacy of pain and function through ASES Shoulder Score health questionnaires
ASES score compared to baseline (total score = 100)
Long term efficacy of pain and function through ASES Shoulder Score health questionnaires
ASES score compared to baseline (total score = 100)
Secondary Outcome Measures
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
Percentage improvement in tendon tear size and thickness
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04077190
Brief Title
Safety and Efficacy of Adult Adipose-Derived Stem Cell Injection Into Partial Thickness Rotator Cuff Tears
Official Title
Extension Study of Protocol RC-001b- Safety and Efficacy of Adult Adipose-Derived Stem Cell Injection Into Partial Thickness Rotator Cuff Tears
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
November 1, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
InGeneron, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tears
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
adipose-derived stem cell injection
Arm Type
Experimental
Arm Description
Ultrasound guided injection of 5cc adipose derived stem cells
Arm Title
cortisone injection
Arm Type
Active Comparator
Arm Description
Ultrasound guided injection of cortisone
Intervention Type
Device
Intervention Name(s)
Adipose-derived stem cells
Intervention Description
5cc adipose derived stem cells.
Intervention Type
Device
Intervention Name(s)
cortisone injection
Intervention Description
cortisone injection
Primary Outcome Measure Information:
Title
Long term Safety as indicated through adverse event rate between ADSC and TAU arms
Description
Adverse event rate
Time Frame
at 24 months
Title
Long term Safety as indicated through adverse event rate between ADSC and TAU arms
Description
Adverse event rate
Time Frame
at 36 months
Title
Long term efficacy of pain and function through Short Form-36 Shoulder Score health questionnaires
Description
Short form-36 score compared to baseline (total score = 800)
Time Frame
at 24 months
Title
Long term efficacy of pain and function through Short Form-36 Shoulder Score health questionnaires
Description
Short form-36 score compared to baseline (total score = 800)
Time Frame
at 36 months
Title
Long term efficacy of pain and function through ASES Shoulder Score health questionnaires
Description
ASES score compared to baseline (total score = 100)
Time Frame
at 24 months
Title
Long term efficacy of pain and function through ASES Shoulder Score health questionnaires
Description
ASES score compared to baseline (total score = 100)
Time Frame
at 36 months
Secondary Outcome Measure Information:
Title
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
Description
Percentage improvement in tendon tear size and thickness
Time Frame
at 36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jason Hurd, MD
Organizational Affiliation
Sanford Orthopedics & Sports Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sanford Orthopedics and Sports Medicine - Fargo
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Sanford orthopedics and Sports Medicine - Sioux Falls
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Safety and Efficacy of Adult Adipose-Derived Stem Cell Injection Into Partial Thickness Rotator Cuff Tears
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