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InGeneron’s focus is on creating therapies that help doctors help patients heal themselves, unlocking the healing potential of each patient’s own regenerative cells. These therapies hold promise that the pain-inducing and range-limiting injuries patients endure can be healed safely, efficiently, and cost-effectively.

InGeneron is presently conducting clinical studies for our therapies which follow the regulatory pathways outlined by the U.S. Food and Drug Administration (FDA). We focus on helping patients who are impacted by musculoskeletal conditions, such as rotator cuff tendinopathy, facet joint syndrome and wrist osteoarthritis.

 

Pipeline Overview

Indication
Pre-Clinical
Feasibility Study
Pivotal Study

Rotator Cuff Tendinopathy

Rotator Cuff Tendinopathy

Facet Joint Syndrome

Facet Joint Syndrome

Wrist Osteoarthritis

Wrist Osteoarthritis

 

Regulatory Approval Process

The FDA regulatory approval process is designed to ensure that a medical device is safe and effective before it is allowed to be marketed in the U.S. In the case of our therapies, this process involves two separate phases of clinical studies.

Feasibility Studies are designed to ensure that a medical device for patient use is safe. The patient cohort is generally small, and it involves people who are receiving the specific therapy as well as those who are part of a control group. At the end of the feasibility study, an assessment is made to determine if the medical device is sufficiently safe to proceed to the pivotal study phase.

Pivotal Studies are designed to ensure that a medical device is both safe and effective – in other words, that it achieves the therapeutic results it sets out to do. Pivotal studies involve a larger group of patients and take longer to conduct and complete than feasibility studies. Pivotal studies also involve patients who receive the therapy and those who are in a control group.

Medical devices that the FDA determines to be safe and effective are approved to be marketed and used in the U.S., in accordance with the description on their FDA label.

Here is an overview of InGeneron’s focus area.

Rotator Cuff Tendinopathy

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 rotator cuff tendinopathy patients undergo surgery or nonsurgical treatment, to relieve the pain that rotator cuff tendinopathy causes and to increase the functioning of their rotator cuff and achieve tendon-to-bone healing. Surgical treatment allows repair within an open or arthroscopic procedure. But a recent meta-analysis indicates that these operative techniques may not offer future potential to heal tissue better or improve clinical results [8].

InGeneron’s solution

Doctors who treat rotator cuff tendinopathy patients in our clinical trial remove adipose tissue under local anesthesia from the patient’s abdominal area; isolate the adipose-derived regenerative cells from the sample using our centrifuge 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, start to finish.

For Doctors – Clinical studies show promise that this therapy will provide a safe, efficient, and effective way for doctors to repair rotator cuff tears [9-11].

For Patients – The procedure is a one-time, minimally invasive outpatient therapy designed to restore shoulder function and minimize pain.

Clinical Trial Status – The feasibility study is completed. Data is being analyzed and will be released in the near future. A pivotal study is presently enrolling patients. Completing successful feasibility study and pivotal study trials and receiving approval of an FDA premarket approval application will allow us to market our rotator cuff tendinopathy therapy in the U.S.

Click here for a regulatory trial status via the ClinicalTrials.gov website.

 

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

We are conducting a feasibility study to investigate the use of ADRCs as a therapeutic treatment for facet joint syndrome that potentially provides an alternative to major surgery and current treatment options.

Clinical Trial Status – The FDA has granted approval to proceed with a feasibility study evaluating InGeneron’s regenerative cell therapy as a way to treat facet joint syndrome. Patient recruitment has begun.

Click here for a regulatory trial status via the ClinicalTrials.gov website.

 

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.

Current treatment options

There are presently nonsurgical and surgical interventions to address wrist osteoarthritis, but these options sometimes do not offer long-term pain relief or a significant improvement in grip strength. Surgical treatments are highly invasive.

InGeneron’s solution

We are conducting a feasibility study to investigate the use of ADRCs as a therapeutic treatment for wrist osteoarthritis that potentially provides a better option for patients.

Clinical Trial Status – The FDA has granted approval to proceed with a feasibility study evaluating InGeneron’s regenerative cell therapy as a way to treat wrist osteoarthritis. Patient recruitment has begun.

Click here for a regulatory trial status via the ClinicalTrials.gov website.