Degenerative Disc Disease

Degenerative disc disease (DDD) is a chronic and progressive disease that is characterized by inflammation and breakdown of tissue within the intervertebral disc. 

Located between the vertebral bones in the spine, the intervertebral disc acts like a pillow to cushion and evenly distribute pressure cross the vertebrae. Each disc is comprised of an outer fibrous ring, the annulus fibrosis, which surrounds an inner gel-like center, the nucleus pulposus.

 

When the intervertebral disc becomes inflamed and loses its structure, the disc tissue becomes rigid and weakened, and begins to collapse. This can result in pressure being applied to the surrounding nerves in the spinal column, causing pain and loss of function.

DDD in the lower back can cause acute or chronic pain at the site of degeneration and may also be felt radiating into the hips, buttocks, thighs or legs. Pain is most commonly felt or made worse by movements such as sitting, bending, lifting or twisting.

Current treatment options include pain management (including opioid use), physical therapy, steroid injections, ablation, chiropractic care and other alternative remedies in the earlier stages, and surgical intervention in the later stages.

 

Clinical Trials

DiscGenics is conducting a prospective randomized double-blinded, vehicle- and placebo-controlled, multicenter clinical study in the U.S. among subjects with single-level, symptomatic lumbar DDD.

The purpose of this research, which has been allowed by the U.S. Food and Drug Administration (FDA), is to study the safety and preliminary efficacy of IDCT, a non-surgical cell therapy for the treatment of DDD.

For more information about our U.S. clinical trial for DDD, including enrollment criteria and participating sites, please:

Expanded Access Policy

DiscGenics is committed to developing cell therapies for patients with degenerated disc disease. Our goal is to bring these treatments to patients as safely and quickly as possible.  We are currently conducting clinical trials to assess the safety and efficacy of our investigational product. DiscGenics believes that participation in our ongoing clinical trial is the best way for patients to access the product. Data generated from these studies is provided to regulatory authorities as part of the product approval process.  

We recognize that there are patients with degenerated disc disease who do not qualify for our trial and these patients may be interested in accessing the investigational cell therapy prior to regulatory approval through expanded access (i.e., compassionate use).  Expanded access refers to the use of an investigational therapy (one that has not been approved by the U.S. Food & Drug Administration (FDA) or other applicable regulatory authority) outside of a clinical trial where more comprehensive safety and efficacy data are collected.

According to the US FDA and other regulatory agencies, expanded access may be appropriate if all of the following apply:

  • The patient has a serious disease or condition, or whose life is immediately threatened by their disease or condition;

  • There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition;

  • Patient enrollment in a clinical trial is not possible;

  • Potential patient benefit based on available safety and efficacy information justifies the potential risks of treatment;

  • Providing the investigational medical product will not interfere with, or delay, investigational trials that could support a medical product’s development or marketing approval for the treatment indication.

In the interest of ensuring material availability for clinical enrollment programs DiscGenics does not offer an expanded access program at this time.  We believe participating in our trial is the most appropriate way to access our investigational product.

For more information on the clinical trial please visit 

https://www.clinicaltrials.gov/ct2/show/NCT03347708?term=discgenics&rank=2

If you have additional questions, please contact info@discgenics.com. Responses will be provided within seven calendar days.

Consistent with the 21st Century Cures Act, DiscGenics may revise this policy at any time.

Understanding Cell Therapy Regulations

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While DiscGenics is advancing its DDD treatment through a stringent regulatory process, not all cell therapies are required to adhere to the same level of regulatory rigor.

Some cell-based therapies, like IDCT, undergo significant transformation during the manufacturing process and are subject to clearance by regulatory body (e.g. FDA, EMA, PMDA, etc.). On the other hand, some may be only minimally manipulated prior to application and thereby are not required to abide by regulations that ensure the safety and efficacy of a treatment.

Before beginning treatment of any kind, we encourage patients and their families to understand the rigorous levels of testing for safety and efficacy a product has undergone before considering it as a treatment for themselves or loved ones.

 

Disclaimer: IDCT is an investigational product that is under development by DiscGenics and has not been approved by the FDA or any other regulatory agency for human use.

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