Precision Spine Care | Tyler, TX
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About
This is a double-blind, saline-controlled, and 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.
Full description
This is a double-blind, saline-controlled, and 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.
Subjects randomized to active treatment will undergo bone marrow harvest for processing into BRTX-100 for intradiscal injection. Subjects randomized to control will also undergo a bone marrow and blood harvest but only receive saline intradiscal injection procedures. Subjects will return to the study site for a visit at Week 2, Week 12, Week 26, Week 52 and Week 104/Early Termination.
The trial will have a Safety Run-In component that will insert a 3+3 design for the initial subjects dosed with BRTX-100 at 40 × 106 cells. Specifically, the randomization scheme will be briefly shifted from the overall trial 2:1 randomization to an initial 3:1 allotment of intradiscal BRTX-100 versus saline control. As such, four subjects will initially be randomized and administered their agents. There will be a 14 day safety follow-up period that must elapse between dosing of each of the first four (4) subjects. Dosing of each subsequent subject in the Safety Run-In component cannot occur until the independent Medical Monitor (MM) reviews the previously-dosed subject's blinded data, including but not limited to physical examination findings, laboratory values and reported adverse events (AEs) and serious adverse events (SAEs), at the completion of the 14-day visit and documents the findings. If no potential dose- limiting toxicity (DLT) is noted by the MM, the MM will approve the dosing of the next subject. If a potential DLT is noted by the MM, the MM will request that an ad hoc Data Safety Monitoring Board (DSMB) review of unblinded data occur per DSMB Charter before the next subject is dosed.
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Inclusion and exclusion criteria
Subject Inclusion Criteria:
A subject is eligible for inclusion if all the following criteria are met:
A high index of suspicion for discogenic pain, (i.e., painful degenerative disc(s) with or without protrusions < 5 mm)
Has degenerative disc disease (DDD) as defined by the following:
Aged 18 to 60 years
Willing and able to provide written informed consent
No evidence of contraindications to the procedure such as pregnancy, active infection, bleeding disorder, or metastatic cancer.
Subject Exclusion Criteria
A subject is not eligible to participate if any of the following criteria are met:
Primary purpose
Allocation
Interventional model
Masking
99 participants in 2 patient groups, including a placebo group
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Central trial contact
Francisco Silva
Data sourced from clinicaltrials.gov
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