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

Not Applicable

Completed

• Conditions: Rotator Cuff Tears
• Interventions: Device: Adipose-derived stem cells; Device: cortisone injection

• Registration Number: NCT04077190
• Lead Sponsor: InGeneron, Inc.

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.

Study Timeline

• Study Start: 2019-08-01
• Study First Submitted: 2019-08-23
• Study First Submitted QC: 2019-09-03
• Study First Posted: 2019-09-04
• Primary Completion: 2021-11-01
• Study Completion: 2021-12-01
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-02
• Last Update Posted: 2022-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
adipose-derived stem cell injection	Adipose-derived stem cells	Ultrasound guided injection of 5cc adipose derived stem cells
cortisone injection	cortisone injection	Ultrasound guided injection of cortisone

Primary Outcome Measures

Name	Time	Method
Long term efficacy of pain and function through Short Form-36 Shoulder Score health questionnaires	at 36 months	Short form-36 score compared to baseline (total score = 800)
Long term Safety as indicated through adverse event rate between ADSC and TAU arms	at 36 months	Adverse event rate
Long term efficacy of pain and function through ASES Shoulder Score health questionnaires	at 36 months	ASES score compared to baseline (total score = 100)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Sanford Orthopedics and Sports Medicine - Fargo; 🇺🇸 Fargo, North Dakota, United States

Sanford orthopedics and Sports Medicine - Sioux Falls; 🇺🇸 Sioux Falls, South Dakota, United States