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By Julian Richard,Benzinga
Chroniclumbar disc disease (cLDD) is a debilitating condition affectingmillions of people worldwide. It is characterized by back pain,stiffness, and restricted movement due to damage to the bony discs inthe lower back. While its exact cause is unknown, factors such as age,obesity, poor posture, and overuse of the lumbar spine are believed tobe contributing factors.
The burden of chronic lumbar disc disease is significant, withthe World Health Organization estimating that up to 75% of adults willexperience some form of chronic back pain throughout their lifetime.It is also estimated that 10-15% of those affected will have along-term disability due to their condition.
To address the unmetneed for an effective and safe way of treating this burdensomecondition, BioRestorative Therapies (NASDAQ: BRTX) launched aPhase 2 double-blind, controlled, randomized study of BRTX-100 in 99American patients. BRTX-100 is an innovative technology that uses thepatient’s cells to repair damage to discs in theback.
Phasing Into Bigger Future Production?
The phase 2 study isevaluating the initial efficacy and safety of a single dose ofBRTX-100 compared to saline injected into the affected disk in thespine. Although the primary endpoints will be unblinded after all 99patients have been treated, a critical milestone for BRTX is scheduledin March or April 2023 related to the safety profile of the product.
An independentgroup of experts will assess the safety data of the first fourpatients treated in the study. This board of experts decides if astudy can continue, if there needs to be changes in the way the studyis conducted or if the study should be stopped entirely. BRTX isconfident that the data from the study will show that BRTX-100 is safein treating cLLD.
The outcome of the board examination will have a criticalimpact on its next moves — “Our advances in stem cell biology anddelivery protocols harbor great promise in conditioning our bodies’own regenerative potential to treat major diseases more effectivelythan current interventions.”
In anticipation of positive findings from thisstudy, BRTX is increasing its manufacturing and quality controlcapacity and hiring new scientists to meet the demands for theBRTX-100 Phase 2 enrollment. The additional demand is expected notonly for the phase 2 study in cLLD but for studies in other conditionsaffecting the neck, knee and hip. Clearing the safety hurdle of thetrial enables the Company to expand its BRTX-100 platform into otherindications more easily and at a greater pace.
Other companies in thestem cell therapy sector of the biotech industry include Sanofi (NASDAQ: SNY), Vertex Pharmaceuticals (NASDAQ: VRTX) and BioMarin Pharmaceutical (NASDAQ: BMRN).
Visit biorestorative.com for more information on the company and its product candidates.
This article wasoriginally published on Benzinga .
BioRestorativeTherapies was founded by scientists and researchers committed todeveloping stem cell therapies to address unmet needs in patients withhighly prevalent conditions.Our advances in stem cell biology anddelivery protocols harbor great promise in conditioning our bodies’own regenerative potential to treat major diseases more effectivelythan current interventions.Today, BioRestorative is activelydeveloping programs that aim to dramatically increase quality of carefor both (i) chronic back pain caused by disc degeneration, as well as(ii) metabolic disorders including obesity anddiabetes.
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