Clinical trial NCT05400798: A Longitudinal, Multi-Center Safety Study of Autologous Adult Adipose-Derived Regenerative Cell Injection Into Chronic Partial-Thickness Rotator Cuff Tears
Official title: A Longitudinal, Multi-Center Safety Study of Autologous Adult Adipose-Derived Regenerative Cell Injection Into Chronic Partial-Thickness Rotator Cuff Tears
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Partial Thickness Rotator Cuff Tear
Lead sponsor: InGeneron, Inc.
Sponsor class: INDUSTRY
First posted: 2022-06-02
Enrollment: 246
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a longitudinal follow-up study of the RC-002 study, in which up to 246 subjects assigned to two randomization arms will be enrolled: an adipose-derived regenerative cell (ADRC) injection arm (ADRC treatment arm) and the SOC corticosteroid injection arm (active control arm). All subjects will be randomly assigned to ADRC treatment or active control arms in a 2:1 ratio and will be followed up for 6 months.

The goal of the RC-004 study is to enroll all patients that were enrolled and treated in RC-002 and follow for 3 years.


Eligibility criteria: Inclusion Criteria:

* 1. Subjects must have completed RC-002.
* 2. Subjects can give appropriate consent.

Exclusion Criteria:

* 1. Subjects who require the use of index arm for ambulation or mobilization via wheelchair, walker, crutches or cane.
* 2. Subjects whose pain behavior or pain medication usage is, in the opinion of the Investigator, out of proportion to the underlying clinical condition or could interfere with the study-required assessments.
* 3. Subject is on an active regimen of chemotherapy or radiation-based treatment.
* 4. Subject is part of a vulnerable population who, in the judgment of the Investigator, is unable to give informed consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include individuals with a mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention.
* 5. Uncooperative subjects or those with neurological/psychiatric disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations.

Primary outcomes:
measure: Primary Endpoint- Safety
timeFrame: 12 months
measure: Primary Endpoint- Safety
timeFrame: 12 months
Secondary outcomes:
measure: Percentage of subjects who demonstrate ≥ 14 mm improvement in VAS - Pain score compared to baseline
timeFrame: 12 months
measure: Percentage of subjects who demonstrate improvement or no worsening of supraspinatus strength on the MRC Muscle Scale compared to baseline
timeFrame: 12 months
measure: Mean improvement in VAS - Pain score compared to baseline
timeFrame: 12 months
measure: Mean improvement in WORC score compared to baseline
timeFrame: 12 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: La Mesa
country: United States
facility: Biosolutions Clinical Research Center
state: California
city: Pasadena
country: United States
facility: Lotus Clinical Research, LLC
state: California
city: Coral Springs
country: United States
facility: Sports and Orthopedic Center
state: Florida
city: Doral
country: United States
facility: Universal Axon Clinical Research
state: Florida
city: Gulf Breeze
country: United States
facility: Andrews Institute for Orthopedics and Sports Medicine
state: Florida
city: Marietta
country: United States
facility: Georgia Institute for Clinical Research
state: Georgia
city: New Orleans
country: United States
facility: Tulane University School of Medicine
state: Louisiana
city: Sioux Falls
country: United States
facility: Sanford Orthopedic Clinic/Research
state: South Dakota
city: Houston
country: United States
facility: HD Research
state: Texas
city: San Antonio
country: United States
facility: Texas Center for Cell Therapy and Research
state: Texas
Study officials:
affiliation: InGeneron, Inc.
name: Christopher Alt, MD
role: STUDY_DIRECTOR
References: