What side effects are associated with this type of intervention?

Common treatments for Transverse Myelitis include high-dose corticosteroids, plasmapheresis, and immunosuppressive therapies. Side effects of these treatments can include increased risk of infections, weight gain, hypertension, and osteoporosis. For cellular therapies like Q-Cells® (glial progenitor cells), potential side effects observed in similar studies include immune reactions, graft rejection, and local inflammation at the injection site. Continuous monitoring for adverse effects is essential in these advanced therapies.

What prior FDA approvals exist?

As of now, there are no FDA-approved treatments specifically for Transverse Myelitis that involve glial progenitor cells or similar cell-based therapies for remyelination and trophic support. Current treatments for Transverse Myelitis primarily focus on managing symptoms and include corticosteroids, plasma exchange therapy, and immunosuppressive drugs. The Q-Cells® trial represents an investigational approach aiming to repair spinal cord damage through the transplantation of glial progenitor cells, which is not yet an FDA-approved treatment.

What other types of research exist?

Promising novel alternatives to Q-Cells® for Transverse Myelitis patients include: 1) Mesenchymal Stem Cells (MSCs) which have shown potential in reducing inflammation and promoting tissue repair; 2) Induced Pluripotent Stem Cells (iPSCs) that can be differentiated into oligodendrocyte precursor cells for remyelination; 3) High-dose Methylcobalamin, which has demonstrated neuroprotective effects in preclinical models; and 4) Neurotrophic factors such as Brain-Derived Neurotrophic Factor (BDNF) and Glial Cell Line-Derived Neurotrophic Factor (GDNF) that support neuronal survival and repair.

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Glial Progenitor Cells

Q-Cells Transplantation for Transverse Myelitis

Phase 1 & 2

Recruiting

Research Sponsored by Q Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject is 18 - 70 years of age (inclusive) on day of Screening Visit

Subject has a MRI with a single focus of T2 hyperintensity that is 4 to 10 cm in length if no post contrast enhancement seen, or a single focus T1 post contrast enhancing lesion of 4 to 10 cm, with its most rostral extent at or below C8 myotome/dermatome level

Must not have

Abnormal flow voids on the surface of the spinal cord suggestive of arteriovenous malformation (AVM) or evidence of a vascular cause of a myelopathy (e.g., infarct of spinal artery)

Subjects with hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT) such as Lesch-Nyhan and Kelley-Seegmiller syndrome

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 9-months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not explicitly listed but may include typical risks associated with cell transplantation such as immune reactions, infection risk from immunosuppressants used during treatment, and possible complications from surgery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 70 years old.

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My MRI shows a specific type of abnormal area in my spine that is 4 to 10 cm long.

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I will use effective birth control during and up to one year after the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have a history of blood clots.

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I do not have conditions like severe nerve pain or muscle diseases that affect my movement.

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I do not have any major health issues that would make surgery risky for me.

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I have had deep vein thrombosis confirmed by an ultrasound.

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I have been diagnosed with a neurodegenerative disease like ALS, Parkinson's, or Alzheimer's.

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My kidney function is reduced, with a filtration rate below 60 mL/min.

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I have had a stem cell transplant in the past.

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I have severe spinal narrowing or pressure on my spinal cord causing nerve issues.

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I have diabetes or my HgbA1c level is above 6.5.

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I don't have conditions or take medications that conflict with tacrolimus, mycophenolate mofetil, or prednisone.

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I am not immune compromised and do not have conditions like TB that prevent immunosuppression treatment.

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I do not have any brain or spinal cord tumors.

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I have had optic neuritis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 9-months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~9-months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 9-months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability].

Secondary study objectives

Latency and conduction velocities from tibial somatosensory evoked potentials (SSEPs)

Pain Scores on the Visual Analog Scale (VAS)

Score on Ashworth Spasticity Scale

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

0 / 18Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Transverse Myelitis, such as the Q-Cells® trial involving glial progenitor cells, work by remyelinating demyelinated axons and providing trophic support to damaged axons. This is particularly important for Transverse Myelitis patients because the disease involves inflammation and demyelination of the spinal cord, resulting in severe neurological impairments. By enhancing remyelination and supporting axonal health, these treatments aim to restore neurological function and reduce long-term disability.

Neuroprotective effects of mesenchymal stem cells on spinal motoneurons following ventral root axotomy: synapse stability and axonal regeneration.