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

Rotator Cuff Tears Clinical Trial

Official title:

Extension Study of Protocol RC-001b- Safety and Efficacy of Adult Adipose-Derived Stem Cell Injection Into Partial Thickness Rotator Cuff Tears

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04077190
• Other study ID #: RC-003
• Status: Completed
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: December 1, 2021

Study information

• Verified date: August 2022
• Source: InGeneron, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 1, 2021
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tears

Intervention

Device:
• Adipose-derived stem cells
5cc adipose derived stem cells.
• cortisone injection
cortisone injection

Locations

Country	Name	City	State
United States	Sanford Orthopedics and Sports Medicine - Fargo	Fargo	North Dakota
United States	Sanford orthopedics and Sports Medicine - Sioux Falls	Sioux Falls	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
InGeneron, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long term Safety as indicated through adverse event rate between ADSC and TAU arms	Adverse event rate	at 24 months
Primary	Long term Safety as indicated through adverse event rate between ADSC and TAU arms	Adverse event rate	at 36 months
Primary	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
Primary	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
Primary	Long term efficacy of pain and function through ASES Shoulder Score health questionnaires	ASES score compared to baseline (total score = 100)	at 24 months
Primary	Long term efficacy of pain and function through ASES Shoulder Score health questionnaires	ASES score compared to baseline (total score = 100)	at 36 months
Secondary	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