Drugs / IDCT
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT03955315 | May 2019 → Feb 2022 | lumbar disk degenerative disorder | DiscGenics, Inc. | Completed | Met primary |
News releases announcing trial results or a regulatory action · 18
| Date | Issuer | Release |
|---|---|---|
| 2026-06-09 | DiscGenics, Inc. | Results DiscGenics Announces Independent DSMB Safety Review Supports Continuation of Phase III Study of IDCT Without Modifications discgenics.com ↗
Following its review of available safety data, the DSMB recommended continuation of the study as planned, with no changes to the study protocol. |
| 2025-10-23 | DiscGenics, Inc. | Results DiscGenics and Collaborators Announce Breakthrough in Tissue-Engineered Intervertebral Disc Research discgenics.com ↗
Through this ongoing collaboration, researchers determined that eDAPS manufactured using DiscGenics’ proprietary nucleus pulposus (NP) and annulus fibrosus (AF) Discogenic Cells are mechanically and biochemically distinct from eDAPS seeded with mesenchymal stem cells (MSCs), offering superior functionality. |
| 2025-04-09 | DiscGenics, Inc. | Results Peer-Reviewed Article Reporting DiscGenics’ Cell Therapy Phase I/II Study Results Receives International Journal of Spine Surgery Best Paper Award discgenics.com ↗
The publication reported results from the combined Phase I/II clinical study of allogeneic disc progenitor cell therapy (IDCT or rebonuputemcel) for painful lumbar degenerative disc disease (DDD). |
| 2024-07-16 | DiscGenics, Inc. | Regulatory DiscGenics Announces US FDA Approval to Proceed with Phase III Clinical Evaluation of Allogeneic, Injectable Disc Progenitor Cell Therapy for Symptomatic Lumbar Degenerative Disc Disease discgenics.com ↗ |
| 2024-07-09 | DiscGenics, Inc. | Results The International Journal of Spine Surgery Has Published Results from an FDA-Approved Study of an Allogeneic Disc Progenitor Cell Therapy for the Treatment of Adults with Lumbar Disc Degeneration discgenics.com ↗
The study met the primary safety and efficacy endpoints, showing that a single intradiscal injection of high-dose IDCT (9,000,000 cells/mL) safely increases disc volume and produces statistically significant, clinically meaningful improvements in back pain, disability, and quality of life out to 2 years post-injection in patients with lumbar disc degeneration. |
| 2023-01-26 | DiscGenics, Inc. | Regulatory DiscGenics Announces FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to IDCT for Degenerative Disc Disease discgenics.com ↗
DiscGenics, Inc. , a clinical stage biopharmaceutical company focused on developing cell-based regenerative therapies that alleviate pain and restore function in patients with degenerative diseases of the spine, today announced the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to Injectable Disc Cell Therapy (IDCT or rebonuputemcel), an injectable, allogeneic discogenic progenitor cell therapy for the treatment of symptomatic lumbar degenerative disc disease (DDD). |
| 2023-01-23 | DiscGenics, Inc. | Results DiscGenics Announces Positive Two-Year Clinical Data from Study of Discogenic Progenitor Cell Therapy for Degenerative Disc Disease discgenics.com ↗
Discogenic progenitor cell therapy safely increased disc volume and provided rapid, durable improvements in low back pain, function, quality of life, and pain medication usage out to two years post-injection in patients with lumbar DDD. |
| 2022-10-05 | DiscGenics, Inc. | Results DiscGenics to Present at 2022 Cell and Gene Meeting on the Mesa discgenics.com ↗
As Flanagan will discuss, improvements were sustained at the 52- and 78-week interim readouts with additional data to follow at 104 weeks. |
| 2022-02-25 | DiscGenics, Inc. | Results DiscGenics Announces Presentation of Positive Interim Clinical Data from Phase 1/2 Study of Cell Therapy for Degenerative Disc Disease discgenics.com ↗
The primary efficacy endpoint of the study (n=60) was achieved, with statistically significant improvement in back pain observed in the high dose IDCT group. |
| 2020-01-07 | DiscGenics, Inc. | Results Japanese Clinical Study of DiscGenics' Cell Therapy for Disc Degeneration Passes Initial Safety Review discgenics.com ↗
The DSMC reported there were no safety issues and recommended that the study continue with no changes to the protocol. |
| 2019-10-28 | DiscGenics, Inc. | Results DiscGenics Announces U.S. Clinical Study of Cell Therapy for Disc Degeneration Clears Final Planned Safety Review discgenics.com ↗
The DSMC reported there were no safety issues and recommended that the study proceed with completion of patient enrollment with no changes to the protocol. |
| 2019-09-24 | DiscGenics, Inc. | Results DiscGenics Announces Publication of Preclinical Data for Disc Degeneration Treatment in The Spine Journal discgenics.com ↗ |
| 2019-09-16 | DiscGenics, Inc. | Results DiscGenics’ U.S. Clinical Study of Cell Therapy for Disc Degeneration Passes Halfway Mark discgenics.com ↗
Upon completing enrollment of the first 30-subject cohort, an independent data safety monitoring committee (DSMC) conducted its second planned safety review and reported there were no safety issues. |
| 2019-08-26 | DiscGenics, Inc. | Regulatory DiscGenics Receives FDA Fast Track Designation for Cell Therapy for Disc Degeneration discgenics.com ↗
DiscGenics, Inc . , a clinical stage biotechnology company focused on developing regenerative cell-based therapies that alleviate pain and restore function in patients with degenerative diseases of the spine, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its investigational cell therapy, IDCT |
| 2019-01-07 | DiscGenics, Inc. | Results DiscGenics Announces that Cell Therapy IDCT has Passed the Initial Safety Review of its First-in-Human Clinical Trial for Degenerative Disc Disease discgenics.com ↗
The DSMC reported there were no safety issues and recommended that the trial continue with no changes to the protocol. |
| 2018-12-11 | DiscGenics, Inc. | Regulatory DiscGenics Receives Approval from Japanese Pharmaceuticals and Medical Devices Agency to Begin Clinical Evaluation of Non-Surgical Degenerative Disc Disease Treatment in Japan discgenics.com ↗
The CTN approval allows DiscGenics to advance IDCT into clinical studies in Japan. |
| 2018-03-22 | DiscGenics, Inc. | Results DiscGenics Presents Promising Preclinical Study Results at ORS 2018 discgenics.com ↗
The studies highlight the safety and regenerative capacity of Discogenic Cells, the active ingredient in the Company’s lead product candidate, IDCT, an allogeneic (donor-derived), noninvasive cell therapy for the treatment of degenerative disc disease (DDD). |
| 2017-10-03 | DiscGenics, Inc. | Regulatory DiscGenics Receives FDA Allowance of IND to Commence Clinical Study of Its Degenerative Disc Disease Therapy discgenics.com ↗ |
All press releases naming this drug 22 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | IDCT | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03955315 ↗ |
| Action | Restore | “The cells produce extracellular matrix that may rebuild the depleting tissue within degenerating discs.” PMID 31442616 ↗ Aug 2019 |
| Modality | Cell therapy | “an investigational cell therapy for disc degeneration.” PMID 31442616 ↗ Aug 2019 |
| Route | Other | “intradiscal injections of two doses of IDCT” NCT03955315 ↗ |