drugset / Trial / NCT04042844

A Single Dose of BRTX 100 for Patients With Chronic Lumbar Disc Disease (cLDD)

NCT04042844 ↗

Phase 2 Recruiting 99 enrolled BioRestorative Therapies
RandomizedParallel-groupDouble-blindTreatment

Summary

This is a double-blind, controlled, randomized study with blinded assessments using a single dose. Subjects that have a current diagnosis of chronic lumbar disc disease and meet eligibility criteria will be enrolled. Chronic lumbar disc disease is defined as back and/or radicular pain with degeneration of the disc confirmed by patient history, physical examination, and radiographic measures such as computed tomography (CT), magnetic resonance imaging (MRI), plain film, myelography, discography, or other acceptable means.

Timeline

Start
2022-06-30
Primary completion
2026-12
Completion
2027-12

Drugs

EvaluationDrugModalityDoseRoute
Subject BRTX-100 Cell therapy 40 cells Intrathecal

Indications