Clinical trial NCT04077190: Safety and Efficacy of Adult Adipose-Derived Stem Cell Injection Into Partial Thickness Rotator Cuff Tears
Official title: Extension Study of Protocol RC-001b- Safety and Efficacy of Adult Adipose-Derived Stem Cell Injection Into Partial Thickness Rotator Cuff Tears
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Tears
Lead sponsor: InGeneron, Inc.
Sponsor class: INDUSTRY
First posted: 2019-09-04
Enrollment: 15
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Long term Safety as indicated through adverse event rate between ADSC and TAU arms
timeFrame: at 24 months
measure: Long term Safety as indicated through adverse event rate between ADSC and TAU arms
timeFrame: at 36 months
measure: Long term efficacy of pain and function through Short Form-36 Shoulder Score health questionnaires
timeFrame: at 24 months
measure: Long term efficacy of pain and function through Short Form-36 Shoulder Score health questionnaires
timeFrame: at 36 months
measure: Long term efficacy of pain and function through ASES Shoulder Score health questionnaires
timeFrame: at 24 months
measure: Long term efficacy of pain and function through ASES Shoulder Score health questionnaires
timeFrame: at 36 months
Secondary outcomes:
measure: 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
timeFrame: at 36 months
Other outcomes:
Locations:
city: Fargo
country: United States
facility: Sanford Orthopedics and Sports Medicine - Fargo
state: North Dakota
city: Sioux Falls
country: United States
facility: Sanford orthopedics and Sports Medicine - Sioux Falls
state: South Dakota
Study officials:
affiliation: Sanford Orthopedics & Sports Medicine
name: jason Hurd, MD
role: PRINCIPAL_INVESTIGATOR
References: