Q-Cells Transplantation for Transverse Myelitis

Overseen By Erev King

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Q Therapeutics, Inc.

Must not be taking: Antidepressants, Immunosuppressants

Disqualifiers: Cognitive impairment, Neurodegenerative disease, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

9 Participants Needed

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.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that certain medications may be contraindicated with the study treatment, so it's best to discuss your specific medications with the study team.

How is the Q-Cells treatment different from other treatments for transverse myelitis?

Q-Cells treatment is unique because it involves transplanting glial cells, which are specialized cells that can help repair damaged nerve coverings (myelin) in the spinal cord. This approach aims to restore function by remyelinating areas affected by transverse myelitis, a method not typically used in standard treatments for this condition. ^{1 2 3 4 5}

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative/Treatment

Participants receive a single time point administration of Q-Cells® with transplantation foci targeted to posterior columns in the spinal cord

1 day

1 visit (in-person)

Post-treatment

Participants are monitored for safety and activity following the transplantation

9 months

Regular visits (in-person)

Long-term follow-up

Subjects who consent will continue to be followed for safety and activity in a separate long-term follow-up protocol

Treatment Details

Interventions

• Q-Cells®

Trial Overview The 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

Group I: Q-Cells dose level 3 Experimental Treatment 1 Intervention

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

Group II: Q-Cells dose level 2 Experimental Treatment 1 Intervention

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

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

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

Who Is Running the Clinical Trial?

Q Therapeutics, Inc.

Lead Sponsor

Trials

2

Recruited

40+

References

1. United States pubmed.ncbi.nlm.nih.gov

Restoration of function by glial cell transplantation into demyelinated spinal cord. [2005]

2. United States pubmed.ncbi.nlm.nih.gov

Xenotransplantation of transgenic oligodendrocyte-lineage cells into spinal cord-injured adult rats. [2006]

3. England pubmed.ncbi.nlm.nih.gov

Remyelinating the demyelinated CNS. [2019]

4. Germany pubmed.ncbi.nlm.nih.gov

Repair of demyelinated lesions by glial cell transplantation. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Transplantation options for therapeutic central nervous system remyelination. [2022]