Safety and Efficacy of Adult Adipose-Derived Stem Cell Injection Into Partial Thickness Rotator Cuff Tears

InGeneron

Status: Completed

Conditions: Rotator Cuff Tears

Treatments: Device: cortisone injection; Device: Adipose-derived stem cells

Study type: Interventional

Funder types: Industry

Identifiers

NCT04077190

RC-003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

15 participants in 2 patient groups

adipose-derived stem cell injection

Experimental group

Description:

Ultrasound guided injection of 5cc adipose derived stem cells

Treatment:

Device: Adipose-derived stem cells

cortisone injection

Active Comparator group

Description:

Ultrasound guided injection of cortisone

Treatment:

Device: cortisone injection