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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| adipose-derived stem cell injection | Experimental | Ultrasound guided injection of 5cc adipose derived stem cells |
|
| cortisone injection | Active Comparator | Ultrasound guided injection of cortisone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adipose-derived stem cells | Device | 5cc adipose derived stem cells. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Long term Safety as indicated through adverse event rate between ADSC and TAU arms | Adverse event rate | at 24 months |
| Long term Safety as indicated through adverse event rate between ADSC and TAU arms | Adverse event rate | at 36 months |
| 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) | at 24 months |
| 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) | at 36 months |
| Long term efficacy of pain and function through ASES Shoulder Score health questionnaires | ASES score compared to baseline (total score = 100) | at 24 months |
| Long term efficacy of pain and function through ASES Shoulder Score health questionnaires | ASES score compared to baseline (total score = 100) | at 36 months |
| 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 | Percentage improvement in tendon tear size and thickness | at 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| jason Hurd, MD | Sanford Orthopedics & Sports Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanford Orthopedics and Sports Medicine - Fargo | Fargo | North Dakota | 58103 | United States | ||
| Sanford orthopedics and Sports Medicine - Sioux Falls |
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| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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| cortisone injection |
| Device |
cortisone injection |
|
| Sioux Falls |
| South Dakota |
| 57104 |
| United States |