Share
BRTX-100 is intended for the treatment of chronic lumbar disc disease. Credit: Africa Studio via shutterstock.com.

BioRestorative Therapies has completed enrolment of patients for the safety run-in component of its Phase II clinical trial of BRTX-100 for the treatment of chronic lumbar disc disease (cLDD).

Safety and preliminary efficacy of a single dose of BRTX-100 will be assessed in the controlled, randomised prospective and double-blinded study.

The study will enrol up to 99 patients over 15 sites in the US. They will be randomised to receive either the investigational drug (BRTX-100) or a control in a 2:1 approach.

BioRestorative Therapies CEO Lance Alstodt said: “Positive safety data would enable us to initiate unrestricted enrolment across all of our clinical sites and, of course, establish a strong safety profile for BRTX-100.

“In addition, we would be able to leverage the BRTX-100 platform across other indications within the body on an investigational basis with potentially a shorter timeline from a regulatory pathway perspective.”

A cell therapy, BRTX-100 is formulated from autologous (or a person’s own) cultured mesenchymal stem cells.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Utilising the company’s proprietary technology, the BRT X-100 production process involves collecting a patient’s bone marrow, isolating and culturing stem cells from the bone marrow and cryopreserving the cells.

It is intended to be used for the non-surgical treatment of lumbosacral disc disorders or as a complementary therapeutic to a surgical process. 

Physician will inject BRTX-100  into the patient’s damaged disc in an outpatient setting.

Patients whose pain has not been relieved by using non-invasive procedures and potentially face the prospect of surgery will be treated with BRTX-100.

The company is also developing a cell-based therapy using brown adipose (fat) derived stem cells for treating obesity and metabolic disorders.

Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content.