Rotator Cuff Tears
Conditions
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.
Interventions
5cc adipose derived stem cells.
DEVICEcortisone injection
cortisone injection
Sponsors
InGeneron, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Long term Safety as indicated through adverse event rate between ADSC and TAU arms | at 24 months | Adverse event rate |
| Long term efficacy of pain and function through Short Form-36 Shoulder Score health questionnaires | at 24 months | Short form-36 score compared to baseline (total score = 800) |
| Long term efficacy of pain and function through ASES Shoulder Score health questionnaires | at 24 months | ASES score compared to baseline (total score = 100) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | at 36 months | Percentage improvement in tendon tear size and thickness |
Countries
United States
Outcome results
None listed