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Denver Spine and Pain Institute Announces Initiation of Patient Enrollment for BioRestorative Therapies Phase 2 Clinical Trial to Treat Chronic Lumbar Disc Disease (cLDD)

DENVER, CO., June 28, 2022 – The Denver Spine and Pain Institute is participating in a nationwide FDA-cleared adult stem cell study using a novel treatment for chronic low back pain and has initiated enrollment. The study will test the use of hypoxic, or low oxygen, expanded autologous mesenchymal stem cells isolated from bone marrow and injected directly into the damaged lumbar disc. This minimally invasive procedure may offer an alternative to back surgery for eligible patients with chronic pain from degenerative discs.

 

An estimated 65 million people in the United States suffer from back pain, and often patients ultimately undergo ineffective surgeries after conservative treatment strategies such as physical therapy or medications fail.

“Millions of Americans suffer from chronic back pain,” said Dr. Scott Bainbridge, the lead investigator at The Denver Spine and Pain Institute. “This stem cell-based therapy is at the cutting edge of regenerative medicine and has the potential to create a paradigm shift in the ability to treat disc pain using next generation minimally invasive solutions.”

The Phase 2 clinical study is sponsored by BioRestorative Therapies and is a double-blind controlled, randomized study to evaluate the safety and preliminary efficacy of a single dose intradiscal injection of the Company’s autologous investigational stem cell-based therapeutic, BRTX-100. A total of up to 99 eligible patients will be randomized at up to 15 centers in the United States to receive either the investigational drug (BRTX-100) or control in a 2:1 fashion.

The Denver Spin and Pain Institute is enrolling study participants suffering from low-back pain for a minimum of six months and whose condition has not responded to other, conventional treatments.  Once enrolled, patients are randomly assigned to one of two treatment groups:

 

  1. Patients will receive BRTX-100, a single dose of autologous bone marrow-derived low-oxygen expanded mesenchymal stem cells

 

  1. Patients will receive saline injection

 

Patients will receive a single injection into the target disc and monitored during the trial. Imaging will be used to identify any changes in their disease progression. Use of pain medications, self-reports of pain and assessments of disability, quality of life, productivity and activity will also be evaluated. Repair of the target disc and reduction of chronic pain will be assessed in each patient.

 

For more information, visit our website at https://denverbackpainspecialists.com

 

About The Denver Spine and Pain Institute.

 

The Denver Spine and Pain Institute provides comprehensive pain management care to address issues causing chronic pain. Our team consists of board-certified physicians, physician assistants, nurse practitioners, physical therapists, and behavioral health specialists who deliver the innovative, world class treatments you need to get your life back. In addition, the Denver Spine and Pain Institute offers a range of clinical research studies to our patients to offer novel treatment options for conditions that can be difficult to treat.

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