TriCelX Receives FDA Approval for XytriX ALS Study

FRISCO, TX, UNITED STATES, September 28, 2026 /CourierPR/ -- TriCelX, Inc., a clinical-stage allogeneic biotherapeutics company based in Frisco, Texas, has received clearance from the U.S. Food and Drug Administration to proceed with its Phase 1/2 study of XytriX™ in amyotrophic lateral sclerosis (ALS). This marks the company’s third IND clearance in 2026, following approvals for knee osteoarthritis (IND 32759, April) and chronic traumatic encephalopathy (CTE, IND 32912, June). All three programs are based on the same product, XytriX™, which is derived from human umbilical cord tissue and produced under the company’s manufacturing protocols.

The ALS study, named Protocol TCX-ALS-001, will evaluate the safety and tolerability of XytriX™ in 20 adults with ALS, who are enrolled early, within 18 months of first symptoms and 12 months of diagnosis. The primary objective is to assess the safety and tolerability of the treatment, followed by safety surveillance for up to 24 months. The secondary objective is to gain a preliminary look at the efficacy of XytriX™, specifically whether it can slow the rate of functional decline in ALS patients.

The study will explore the intravenous and intranasal delivery methods of XytriX™. The intranasal route is particularly noteworthy as it is the first time this delivery method will be used with XytriX™. The cells are administered as small drops onto the lining of the nose over about 30 to 45 minutes, bypassing the need for needles or lumbar punctures. This approach leverages the olfactory and trigeminal nerve pathways to deliver the cells directly to the brain and spinal cord, potentially avoiding the blood-brain barrier.

The study will be conducted at the Baylor Scott & White Sports Therapy & Research Center in Frisco, Texas. Each participant will receive three monthly treatment cycles over twelve weeks, with XytriX™ administered on top of their existing ALS medicines. No one will receive a placebo; instead, each participant’s decline will be measured over a 12-week observation period before treatment and compared with their own rate afterward, and against a matched comparator drawn from the PRO-ACT database of completed ALS trials.

The company’s XytriX™ is an investigational biotherapeutic composed of human umbilical cord tissue-derived mesenchymal signaling cells (hUC-MSC), produced under TriCelX’s manufacturing protocols at its FDA-registered facility in Frisco, Texas. The cells act by releasing signals that calm inflammation and support neurons, rather than by replacing tissue. XytriX™ is currently in clinical development for knee osteoarthritis, chronic traumatic encephalopathy, and amyotrophic lateral sclerosis.