Engineered regulatory immune cells to protect nerves in ALS

Development of CM-CS1 CAR Treg to Treat Amyotrophic Lateral Sclerosis (ALS)

['FUNDING_SBIR_2'] · CELDARA MEDICAL, LLC · NIH-11181028

Engineered regulatory immune cells (CAR Tregs) that seek out misfolded SOD1 and calm inflammation around motor neurons in people with ALS.

Quick facts

Phase['FUNDING_SBIR_2']
Study typeNih_funding
SexAll
SponsorCELDARA MEDICAL, LLC (nih funded)
Locations1 site (LEBANON, UNITED STATES)
Trial IDNIH-11181028 on ClinicalTrials.gov

What this research studies

This project creates CAR Treg cells that specifically recognize aggregated misfolded SOD1, a protein found in many ALS patients, and activates those cells where the abnormal protein appears. The engineered Tregs are also programmed to release BDNF, a factor that supports nerve cell survival. The team is testing these cells in a newly developed mouse model that carries the ALS-linked SOD1 mutation on an immune-deficient background to permit human-like cell engraftment. Work focuses on preclinical development to show safety and effectiveness before any human testing.

Who could benefit from this research

Good fit: People diagnosed with ALS, especially those whose disease involves misfolded or aggregated SOD1, would be the most relevant candidates for this approach.

Not a fit: Patients whose ALS does not involve SOD1 aggregation or those with very advanced, irreversible motor neuron loss are less likely to benefit from this therapy.

Why it matters

Potential benefit: If successful, this approach could reduce harmful inflammation around motor neurons and help slow ALS progression.

How similar studies have performed: Regulatory T cell therapies have shown promise in other inflammatory and autoimmune conditions, but CAR Tregs targeting aggregated proteins in ALS is a novel and largely preclinical approach.

Where this research is happening

LEBANON, UNITED STATES

Researchers

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page below.

View on NIH RePORTER →

Conditions: Alzheimer disease dementia, Alzheimer syndrome, Alzheimer's Disease, Amyotrophic Lateral Sclerosis Motor Neuron Disease

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.