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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adipose Derived Regenerative Cells | Experimental | a single injection of adipose-derived regenerative cells (ADRCs) into the partial-thickness rotator cuff tear |
|
| Corticosteroid | Active Comparator | a single corticosteroid injection into the subacromial space of the index arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adipose Derived Regenerative Cells | Device | single injection of adipose-derived regenerative cells (ADRCs) into the partial-thickness rotator cuff tear |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Endpoint- Safety | Incidence (%) severity and seriousness of adverse events (AEs) | 12 months |
| Primary Endpoint- Safety | Incidence (%) of treatment-related adverse events | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects who demonstrate ≥ 14 mm improvement in VAS - Pain score compared to baseline | 12 months | |
| Percentage of subjects who demonstrate improvement or no worsening of supraspinatus strength on the MRC Muscle Scale compared to baseline | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Alt, MD | InGeneron, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Research Center | Phoenix | Arizona | 85053 | United States | ||
| Biosolutions Clinical Research Center |
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| Corticosteroid | Device | a single corticosteroid injection into the associated subacromial space |
|
| Mean improvement in VAS - Pain score compared to baseline | 12 months |
| Mean improvement in WORC score compared to baseline | 12 months |
| La Mesa |
| California |
| 91942 |
| United States |
| Lotus Clinical Research, LLC | Pasadena | California | 91105 | United States |
| Sports and Orthopedic Center | Coral Springs | Florida | 33067 | United States |
| Universal Axon Clinical Research | Doral | Florida | 33166 | United States |
| Andrews Institute for Orthopedics and Sports Medicine | Gulf Breeze | Florida | 32561 | United States |
| Georgia Institute for Clinical Research | Marietta | Georgia | 30060 | United States |
| Tulane University School of Medicine | New Orleans | Louisiana | 70112 | United States |
| Sanford Orthopedic Clinic/Research | Sioux Falls | South Dakota | 57104 | United States |
| HD Research | Houston | Texas | 77041 | United States |
| Texas Center for Cell Therapy and Research | San Antonio | Texas | 78240 | United States |