DiscGenics (Salt Lake City, UT) has treated the first patient in its Phase 3 clinical trial of IDCT, a cell-based therapy targeting lumbar degenerative disc disease, marking a key regulatory and clinical milestone for the company.
Salt Lake City, Utah — January 12, 2026
DiscGenics, Inc. a privately held late-stage biopharmaceutical company focused on regenerative therapies for spinal disorders, announced that the first patient has been treated in its Phase 3 clinical trial evaluating IDCT (injectable disc cell therapy, rebonuputemcel) for lumbar degenerative disc disease (DDD). Site activation for the study is underway across the United States.
The pivotal Phase 3 trial targets patients with single-level, symptomatic mild-to-moderate lumbar DDD, a condition that affects millions and often leaves patients choosing between ineffective conservative care and invasive surgery.
In July 2024, the company announced that it had gained acceptance from the U.S. Food and Drug Administration (FDA) for the clinical protocols and Chemistry, Manufacturing, and Controls (CMC) clinical development plan for Phase 3 clinical program of its allogeneic, injectable disc progenitor cell therapy (IDCT or rebonuputemcel) for painful lumbar degenerative disc disease (DDD), allowing the study to proceed.
The DGX-A02 Phase 3 trial uses a randomized, double-blind, sham-controlled design—considered the gold standard for late-stage clinical evaluation.
“Treating the first patient in our Phase 3 trial marks an important milestone for DiscGenics and for individuals living with lumbar degenerative disc disease,” said Kevin T. Foley, MD, Chief Medical Officer of DiscGenics. “IDCT is designed as a minimally invasive, single-injection outpatient therapy that targets the diseased disc itself. This study is intended to generate the rigorous clinical evidence needed to determine whether IDCT can offer a meaningful alternative for patients with limited treatment options.”
Matthew F. Gornet, MD, spine surgeon at The Orthopedic Center of St. Louis and a principal investigator in earlier DiscGenics trials, treated the first patient enrolled in the Phase 3 study.
“In the Phase 1/2 trial, we observed promising results,” Gornet said. “Participating in this Phase 3 trial allows eligible patients access to an investigational therapy designed to address the underlying disc pathology, not just symptoms. We’re encouraged to help evaluate what could become an important new option for patients with degenerative disc disease.”
“This trial has been carefully structured to assess both safety and efficacy,” said Nagy Mekhail, MD, PhD, of Cleveland Clinic, and Chief Eligibility Officer for the study. “Strict eligibility criteria and standardized outcome measures are intended to produce high-quality data that can inform clinicians, patients, and regulators about the role cell-based therapies may play in managing lumbar degenerative disc disease.”
About the DGX-A02 Phase 3 Trial
DGX-A02 is a multicenter, prospective Phase 3 clinical trial enrolling approximately 162 patients with single-level lumbar disc degeneration between L3 and S1. The study includes a 52-week primary evaluation period followed by an additional 52-week follow-up, for a total study duration of 104 weeks. The trial is registered at ClinicalTrials.gov (NCT07254806).
About IDCT (Injectable Disc Cell Therapy, Rebonuputemcel)
IDCT is an investigational, single-injection biologic therapy intended to slow or halt disc degeneration and promote regeneration of intervertebral disc tissue. The therapy consists of a manufactured progenitor cell population derived from donated adult human disc tissue, delivered via a viscous carrier. IDCT has received both Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the U.S. Food and Drug Administration. It has not been approved for any use.
About DiscGenics
DiscGenics is developing allogeneic, cell-based regenerative therapies for musculoskeletal degeneration. Its lead program, IDCT (rebonuputemcel), is designed as a one-time injection to treat lumbar disc degeneration. The company operates a proprietary, commercial-scale cell manufacturing process and maintains a cGMP facility at its headquarters in Salt Lake City, Utah.
More information is available at discgenics.com.
Initial TechBuzz coverage of DiscGenics can be found here.
