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Partial Thickness Rotator Cuff Tear Study

Sponsored by InGeneron

Treatments

Here at RegeneSpine, we know how much pain can affect your life and relationships.

 

What is the study about?

The clinical study uses regenerative cells in patients who have partial thickness rotator cuff tears. These are tears in the tendon that contribute to shoulder pain, dysfunction, and occupational disability. In this study, regenerative cells from your fat tissue will be isolated, concentrated, and injected into your tendon tear. The trial will evaluate the safety and effectiveness of using these cells to treat patients’ injuries compared to a steroid injection. The study is sponsored by InGeneron, Inc., a cell therapy company developing regenerative medicine therapies for musculoskeletal diseases.

What can I expect if I join the study?

After signing a consent form, you will undergo radiology and lab testing to confirm your diagnosis and ensure it’s safe for you to participate in the study.


Once you pass the screening tests, you will be randomly enrolled in either the treatment or control group.

You won’t know which group you are enrolled in. This is to make sure your answers to any questions during your follow up visits are not influenced by the type of treatment you were given. Your chance of being placed in the treatment group is approximately 66%

Liposuction

Participants in both groups will receive a liposuction procedure of approximately half a cup of fat tissue (about 100 milliliters) taken from their abdomen, trunk, or thigh, using a standard liposuction technique.

Treatment Group

The fat tissue of a person in the treatment group will be processed using an enzyme, which isolates and concentrates regenerative cells located in the tissue. Those cells are then injected into the site of the injury.

Control Group

Patients in the control group will undergo a liposuction procedure and receive a steroid injection. Independent of the group you are enrolled in, you’ll be able to return home after the injection is complete. All procedures will take place on the same day and take approximately six hours total.

How many follow-up vistas are there?

Following the procedure day, you’ll have six follow-up visits with the physician who performed the procedure:

  • At two weeks
  • Six weeks
  • Twelve weeks
  • 24 weeks
  • 36 weeks
  • And 48 weeks after the procedure

These visits will include a physical exam, questions about your health history and medications, surveys, lab testing (at the two week and 48 week visits) and radiographic exams (at the 24 week and 48 week visits).

Who is eligible?

Male and female patients between 40 and 75 years old who both demonstrate clinical symptoms of a partial-thickness rotator cuff tear, and who are diagnosed with partial thickness rotator cuff tears by an MRI, are eligible to participate in the trial. The study team will review with you a detailed list of criteria that’s necessary to be included in the study, and discuss your eligibility.

What are the potential benefits of participation?

Benefits to your participation are not guaranteed, but you could potentially see improved function and decreased pain in your injured rotator cuff, which could improve your overall quality of life.

What are the potential risks?

There are potential risks for participation in this study. For example, the liposuction procedure may result in temporary bruising or soreness. A full list of risks will be reviewed with you by the study team.

What are Regenerative Cells?

Regenerative cells are a mixture of stem and progenitor cells as well as different immune cells (i.e. white blood cells). These cells can be found in a person’s body fat and harvested through a liposuction and processing procedure. Earlier studies suggest that these cells can be used to stimulate repair and regeneration of damaged tissue.

Spinal Ligament Injections

A spinal ligament injection is a minimally invasive procedure in which an injection is performed under x-ray or ultrasound guidance into the ligaments of the spine and surrounding structures.