First clinical study of BioRestorative Therapies' brtxDISC stem cell therapy for protruding or bulging lumbar discs
Phase of Trial: Phase II
Latest Information Update: 08 Feb 2017
At a glance
- Drugs Intervertebral disc stem cell replacement therapy BioRestorative Therapies (Primary)
- Indications Back pain; Intervertebral disc degeneration
- Focus Adverse reactions
- Sponsors BioRestorative Therapies
- 08 Feb 2017 According to a BioRestorative Therapies media release, company received clearance by the U.S. Food and Drug Administration (FDA) to commence this study.
- 09 Jan 2017 According to a BioRestorative media release, company has submitted an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) to seek clearance to commence this trial using its lead cell therapy candidate, BRTX-100, to treat chronic lower back pain due to degenerative disc disease related to protruding/bulging discs.
- 09 Feb 2016 According to a BioRestorative media release, planned initiation date changed from 1 Dec 2015 to 1 Jan 2016.