Study to Evaluate the Safety and Preliminary Efficacy of IDCT, a Treatment for Symptomatic Lumbar Intervertebral Disc Degeneration
Summary
The purpose of this study is to compare the safety and preliminary efficacy of intradiscal injections of two doses of IDCT (Discogenic Cells + Sodium Hyaluronate vehicle) and two controls (saline, Sodium Hyaluronate vehicle) in subjects with chronic low back pain due to Degenerative Disc Disease (DDD) at one lumbar level from L3 to S1.
Timeline
- Start
- 2018-02-26
- Primary completion
- 2022-02-01
- Completion
- 2022-11-10
Outcome
Met primary endpoint
paper At week 52, the high-dose group had a mean VAS percentage decrease from baseline (-62.8%, P = 0.0005), achieving the endpoint of back pain improvement >30%; PMID 38925869 ↗
release “In the FDA-allowed prospective, randomized, double-blind, vehicle- and placebo-controlled, multicenter clinical study, high dose IDCT (9,000,000 cells/mL; n=20) met the primary safety and efficacy endpoints” discgenics.com ↗
release “Phase I/II clinical study of allogeneic disc progenitor cell therapy (IDCT or rebonuputemcel) for painful lumbar degenerative disc disease (DDD). The study met the primary” discgenics.com ↗
release “The study met the primary safety and efficacy endpoints” discgenics.com ↗
Publications
- Gornet MF, Beall DP, Davis TT, Coric D, LaBagnara M, Krull A, DePalma MJ, Hsieh PC, Mallempati S, Schranck FW, Kelly C, Foley KT. Allogeneic Disc Progenitor Cells Safely Increase Disc Volume and Improve Pain, Disability, and Quality of Life in Patients With Lumbar Disc Degeneration-Results of an FDA-Approved Biologic Therapy Randomized Clinical Trial. Int J Spine Surg. 2024 Jul 4;18(3):237-248. doi: 10.14444/8609.
- Silverman LI, Dulatova G, Tandeski T, Erickson IE, Lundell B, Toplon D, Wolff T, Howard A, Chintalacharuvu S, Foley KT. In vitro and in vivo evaluation of discogenic cells, an investigational cell therapy for disc degeneration. Spine J. 2020 Jan;20(1):138-149. doi: 10.1016/j.spinee.2019.08.006. Epub 2019 Aug 20.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | IDCT | Cell therapy | 3 cells | Other |
| Subject | IDCT | Cell therapy | 9 cells | Other |