Back to resultsA Longitudinal, Multi-Center Safety Study of Autologous Adult Adipose-Derived Regenerative Cell Injection Into Chronic Partial-Thickness Rotator Cuff Tears
Primary Purpose
Partial Thickness Rotator Cuff Tear
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Adipose Derived Regenerative Cells
Corticosteroid
Sponsored by
About this trial
This is an interventional other trial for Partial Thickness Rotator Cuff Tear
Eligibility Criteria
Inclusion Criteria:
- 1. Subjects must have completed RC-002.
- 2. Subjects can give appropriate consent.
Exclusion Criteria:
- 1. Subjects who require the use of index arm for ambulation or mobilization via wheelchair, walker, crutches or cane.
- 2. Subjects whose pain behavior or pain medication usage is, in the opinion of the Investigator, out of proportion to the underlying clinical condition or could interfere with the study-required assessments.
- 3. Subject is on an active regimen of chemotherapy or radiation-based treatment.
- 4. Subject is part of a vulnerable population who, in the judgment of the Investigator, is unable to give informed consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include individuals with a mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention.
- 5. Uncooperative subjects or those with neurological/psychiatric disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations.
Sites / Locations
- Arizona Research Center
- Biosolutions Clinical Research Center
- Lotus Clinical Research, LLC
- Sports and Orthopedic Center
- Universal Axon Clinical Research
- Shrock Clinical Research
- Andrews Institute for Orthopedics and Sports Medicine
- Georgia Institute for Clinical Research
- Tulane University School of Medicine
- Sanford Medical Center
- Sanford Orthopedic Clinic/Research
- HD Research
- Texas Center for Cell Therapy and Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Adipose Derived Regenerative Cells
Corticosteroid
Arm Description
a single injection of adipose-derived regenerative cells (ADRCs) into the partial-thickness rotator cuff tear
a single corticosteroid injection into the subacromial space of the index arm
Outcomes
Primary Outcome Measures
Primary Endpoint- Safety
Incidence (%) severity and seriousness of adverse events (AEs)
Primary Endpoint- Safety
Incidence (%) of treatment-related adverse events
Secondary Outcome Measures
Percentage of subjects who demonstrate ≥ 14 mm improvement in VAS - Pain score compared to baseline
Percentage of subjects who demonstrate improvement or no worsening of supraspinatus strength on the MRC Muscle Scale compared to baseline
Mean improvement in VAS - Pain score compared to baseline
Mean improvement in WORC score compared to baseline
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05400798
Brief Title
A Longitudinal, Multi-Center Safety Study of Autologous Adult Adipose-Derived Regenerative Cell Injection Into Chronic Partial-Thickness Rotator Cuff Tears
Official Title
A Longitudinal, Multi-Center Safety Study of Autologous Adult Adipose-Derived Regenerative Cell Injection Into Chronic Partial-Thickness Rotator Cuff Tears
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
March 31, 2026 (Anticipated)
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
5. Study Description
Brief Summary
This is a longitudinal follow-up study of the RC-002 study, in which up to 246 subjects assigned to two randomization arms will be enrolled: an adipose-derived regenerative cell (ADRC) injection arm (ADRC treatment arm) and the SOC corticosteroid injection arm (active control arm). All subjects will be randomly assigned to ADRC treatment or active control arms in a 2:1 ratio and will be followed up for 6 months.
The goal of the RC-004 study is to enroll all patients that were enrolled and treated in RC-002 and follow for 3 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Partial Thickness Rotator Cuff Tear
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
246 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Adipose Derived Regenerative Cells
Arm Type
Experimental
Arm Description
a single injection of adipose-derived regenerative cells (ADRCs) into the partial-thickness rotator cuff tear
Arm Title
Corticosteroid
Arm Type
Active Comparator
Arm Description
a single corticosteroid injection into the subacromial space of the index arm
Intervention Type
Device
Intervention Name(s)
Adipose Derived Regenerative Cells
Intervention Description
single injection of adipose-derived regenerative cells (ADRCs) into the partial-thickness rotator cuff tear
Intervention Type
Device
Intervention Name(s)
Corticosteroid
Intervention Description
a single corticosteroid injection into the associated subacromial space
Primary Outcome Measure Information:
Title
Primary Endpoint- Safety
Description
Incidence (%) severity and seriousness of adverse events (AEs)
Time Frame
12 months
Title
Primary Endpoint- Safety
Description
Incidence (%) of treatment-related adverse events
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Percentage of subjects who demonstrate ≥ 14 mm improvement in VAS - Pain score compared to baseline
Time Frame
12 months
Title
Percentage of subjects who demonstrate improvement or no worsening of supraspinatus strength on the MRC Muscle Scale compared to baseline
Time Frame
12 months
Title
Mean improvement in VAS - Pain score compared to baseline
Time Frame
12 months
Title
Mean improvement in WORC score compared to baseline
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. Subjects must have completed RC-002.
2. Subjects can give appropriate consent.
Exclusion Criteria:
1. Subjects who require the use of index arm for ambulation or mobilization via wheelchair, walker, crutches or cane.
2. Subjects whose pain behavior or pain medication usage is, in the opinion of the Investigator, out of proportion to the underlying clinical condition or could interfere with the study-required assessments.
3. Subject is on an active regimen of chemotherapy or radiation-based treatment.
4. Subject is part of a vulnerable population who, in the judgment of the Investigator, is unable to give informed consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include individuals with a mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention.
5. Uncooperative subjects or those with neurological/psychiatric disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Alt, MD
Organizational Affiliation
InGeneron, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85053
Country
United States
Facility Name
Biosolutions Clinical Research Center
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Lotus Clinical Research, LLC
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Sports and Orthopedic Center
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33067
Country
United States
Facility Name
Universal Axon Clinical Research
City
Doral
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Shrock Clinical Research
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Andrews Institute for Orthopedics and Sports Medicine
City
Gulf Breeze
State/Province
Florida
ZIP/Postal Code
32561
Country
United States
Facility Name
Georgia Institute for Clinical Research
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Tulane University School of Medicine
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Sanford Medical Center
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Sanford Orthopedic Clinic/Research
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Facility Name
HD Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77041
Country
United States
Facility Name
Texas Center for Cell Therapy and Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Longitudinal, Multi-Center Safety Study of Autologous Adult Adipose-Derived Regenerative Cell Injection Into Chronic Partial-Thickness Rotator Cuff Tears
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