Q-Cells Transplantation for Transverse Myelitis

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Q Therapeutics, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests the safety and early effects of transplanting Q-Cells® into the spinal cords of patients with Transverse Myelitis. These special cells may help repair damage and improve function. The study will follow up with participants over several months to monitor their progress.

Research Team

Eligibility Criteria

This trial is for adults aged 18-70 with idiopathic Transverse Myelitis diagnosed within the last 10 years. Participants must be stable, able to travel to the center, and have a caregiver. They should not have other autoimmune diseases or significant medical conditions that could interfere with the study.

Inclusion Criteria

I am between 18 and 70 years old.

Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to collect and use protected health information (PHI) in accordance with national and local subject privacy regulations

I was diagnosed with idiopathic transverse myelitis within the last 10 years.

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Exclusion Criteria

My scans show possible blood vessel issues in my spinal cord.

I have a genetic condition like Lesch-Nyhan or Kelley-Seegmiller syndrome.

You are allergic to the study treatment or any of its parts, like chicken eggs, or to any of the other medications given with it.

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Treatment Details

Interventions

Q-Cells® (Glial Progenitor Cells)

Trial OverviewThe trial tests Q-Cells transplantation into spinal cord lesions in Transverse Myelitis patients. It's an open-label study assessing safety and potential benefits of these glial progenitor cells in repairing nerve damage over a period of up to 12 months post-transplantation.

Participant Groups

3Treatment groups

Experimental Treatment

Group I: Q-Cells dose level 3Experimental Treatment1 Intervention

One time surgical transplantation of Q-Cells dose level 3 unilaterally into spinal cord demyelinated lesion

Group II: Q-Cells dose level 2Experimental Treatment1 Intervention

One time surgical transplantation of Q-Cells dose level 2 unilaterally into spinal cord demyelinated lesion

Group III: Q-Cells dose level 1Experimental Treatment1 Intervention

One time surgical transplantation of Q-Cells dose level 1 unilaterally into spinal cord demyelinated lesion