Trials / Terminated
TerminatedNCT01771471
A Study Comparing the Safety and Effectiveness of Cartilage Cell Injected Into the Lumbar Disc as Compared to a Placebo
A Phase II, Randomized, Double Blind, Placebo Controlled Study Evaluating the Treatment of Degenerative Lumbar Discs With Allogeneic Cultured Chondrocytes
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 44 (actual)
- Sponsor
- ISTO Technologies, Inc. · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
This is a Phase II clinical study to collect additional safety data and preliminary efficiency of juvenile chondrocytes, delivered in fibrin carrier (NuQu®) to the nucleus of lumbar intervertebral discs for the treatment of discogenic pain. This to be accomplished through a double blinded, placebo-controlled study of clinically meaningful endpoints including validated, subject reported outcomes of pain and disability, health related quality of life and subject satisfaction with treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | NuQu | Allogenic juvenile chondrocytes (NuQu) in fibrin carrier. |
| OTHER | Placebo | 0.9% w/v Sodium Chloride for Injection, USP |
Timeline
- Start date
- 2012-11-01
- Primary completion
- 2020-09-01
- Completion
- 2020-09-01
- First posted
- 2013-01-18
- Last updated
- 2017-08-31
Locations
10 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01771471. Inclusion in this directory is not an endorsement.