Pipeline

Clinical Trial Status

• Rotator cuff feasibility study is completed

• Feasibility study data analyzed and published

• Pivotal study is actively enrolling patients

• FDA approval application will follow completion of pivotal trial

Partial-Thickness Rotator Cuff Tear

Every year, more than one million patients in developed economies experience a tear in their supraspinatus tendon, located within their rotator cuff. This is by far the most common orthopedic shoulder injury, and it results in shoulder pain and sometimes an occupational disability. This condition occurs frequently among elderly people, as well as middle-aged patients who are actively involved in athletics that require a frequent overhead movement of their arms and shoulders.

Current Treatment Options

A significant number of partial-thickness rotator cuff tear patients undergo surgery or nonsurgical treatment, to relieve the pain that rotator cuff tendinopathy causes and increase the functioning of their rotator cuff and achieve tendon-to-bone healing. Surgical treatment allows repair utilizing an open or arthroscopic procedure. A recent meta-analysis indicates that these operative techniques may not offer future potential to heal tissue better or improve clinical results.

InGeneron’s Solution

Doctors who treat partial-thickness rotator cuff tear patients in our trial harvest a small sample of adipose tissue under local anesthesia from the patient’s abdominal area; isolate the regenerative cells from the sample using our cell processing unit and an enzyme; and then wash, filter, and inject the cells into that same patient’s shoulder.

The procedure is performed in the clinic on an outpatient basis and generally takes only two hours, from start to finish.

Clinical Trial Status

• Pre-clinical research has been published

• Facet joint feasibility study is currently enrolling patients

• Study results will be published upon trial completion

Facet Joint Syndrome

At least two and a half million people endure chronic back pain, and facet joint syndrome is one of the leading cause of this condition. Facet joint syndrome is associated with the inflammation of a person’s facet joint, which leads to degeneration and cartilage loss.

Current Treatment Options

Many current treatment options to address facet joint syndrome—such as oral pain medication, steroid injection, and nerve ablation—focus on its symptoms rather than its root cause, and therefore provide only short-term relief rather than healing. Spinal fusion,
a procedure to repair the problem, involves major surgery.

InGeneron’s Solution

Doctors who treat Facet Joint Syndrome patients in our trial harvest a small sample of adipose tissue under local anesthesia from the patient’s abdominal area; isolate the regenerative cells from the sample using our cell processing unit and an enzyme; and then wash, filter, and inject the cells into that same patient’s facet joint.

The procedure is performed in the clinic on an outpatient basis and generally takes only two hours, from start to finish.

Clinical Trial Status

• Pre-clinical research has been published

• Wrist osteoarthritis feasibility study is currently enrolling patients

• Study results will be published upon trial completion

Wrist Osteoarthritis

Each year, at least 100,000 people who develop wrist osteoarthritis need an alternative to surgery to treat their ailment. Wrist osteoarthritis can result in bone spurs and bone cysts in the wrist, as well as a degeneration of cartilage. These conditions can cause inflammation and pain and can lead to a reduction in grip strength and limited range of motion.

InGeneron’s Solution

Doctors who Wrist Osteoarthritis patients in our trial harvest a small sample of adipose tissue under local anesthesia from the patient’s abdominal area; isolate the regenerative cells from the sample using our cell processing unit and an enzyme; and then wash, filter, and inject the cells into that same patient’s wrist.

The procedure is performed in the clinic on an outpatient basis and generally takes only two hours, from start to finish.