A Longitudinal, Multi-Center Safety Study of Autologous Adult Adipose-Derived Regenerative Cell Injection Into Chronic Partial-Thickness Rotator Cuff Tears

Обзор

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.

Вмешательства

• Устройство Adipose Derived Regenerative Cells
  single injection of adipose-derived regenerative cells (ADRCs) into the partial-thickness rotator cuff tear
• Устройство Corticosteroid
  a single corticosteroid injection into the associated subacromial space

Первичные конечные точки

• Primary Endpoint- Safety [Срок оценки: 12 months]
• Primary Endpoint- Safety [Срок оценки: 12 months]

Вторичные конечные точки (4)

• Percentage of subjects who demonstrate ≥ 14 mm improvement in VAS - Pain score compared to baseline [Срок оценки: 12 months]
• Percentage of subjects who demonstrate improvement or no worsening of supraspinatus strength on the MRC Muscle Scale compared to baseline [Срок оценки: 12 months]
• Mean improvement in VAS - Pain score compared to baseline [Срок оценки: 12 months]
• Mean improvement in WORC score compared to baseline [Срок оценки: 12 months]

Критерии участия

Критерии включения

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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Другое

Центры проведения

США · 11 центров

• Arizona Research Center — Phoenix
• Biosolutions Clinical Research Center — La Mesa
• Lotus Clinical Research, LLC — Pasadena
• Sports and Orthopedic Center — Coral Springs
• Universal Axon Clinical Research — Doral
• Andrews Institute for Orthopedics and Sports Medicine — Gulf Breeze
• Georgia Institute for Clinical Research — Marietta
• Tulane University School of Medicine — New Orleans
• … и ещё 3 центра

Идентификаторы

NCT: NCT05400798 · RC-004

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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