A Study Comparing the Safety and Effectiveness of Cartilage Cell Injected Into the Lumbar Disc as Compared to a Placebo
NCT01771471 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44
Last updated 2017-08-31
Summary
This is a clinical study to collect safety and preliminary efficiency information on the use of NuQu chondrocytes (cartilage cells) delivered to the center of a lumbar spinal disc to treat low back pain.
Conditions
- Degenerative Disc Disease
Interventions
- BIOLOGICAL
-
NuQu
Allogenic juvenile chondrocytes (NuQu) in fibrin carrier.
- OTHER
-
Placebo
0.9% w/v Sodium Chloride for Injection, USP
Sponsors & Collaborators
-
ISTO Technologies, Inc.
lead INDUSTRY
Principal Investigators
-
Domagoj Coric, MD · Carolina Neurosurgery and Spine Associates
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-11-30
- Primary Completion
- 2020-09-30
- Completion
- 2020-09-30
Countries
- United States
Study Locations
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