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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 is diagnosed with idiopathic TM within the past 120 months in accord with the Transverse Myelitis Consortium Working Group (2002)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9-months
Awards & highlights

Study Summary

This trial is exploring if transplanted Q-Cells® can improve recovery from Transverse Myelitis by remyelinating axons and providing trophic support.

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.Check my eligibility
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.See study design
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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I was diagnosed with idiopathic transverse myelitis within the last 10 years.
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I have someone to help me with travel and care for my study needs.
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It has been over a year since my TM symptoms started.
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My neurological symptoms from TM have been stable for 3 months.
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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 can travel to the center easily or have a reliable way to get there.
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I will use effective birth control during and up to one year after the study.
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I am physically and medically able to follow the study's procedures and visit schedule.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability].
Secondary outcome measures
Latency and conduction velocities from tibial somatosensory evoked potentials (SSEPs)
Pain Scores on the Visual Analog Scale (VAS)
Quantitative muscle strength values from a hand held dynamometer (HHD)
+3 more

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

Find a Location

Who is running the clinical trial?

Q Therapeutics, Inc.Lead Sponsor
1 Previous Clinical Trials
30 Total Patients Enrolled

Media Library

Q-Cells® (Glial Progenitor Cells) Clinical Trial Eligibility Overview. Trial Name: NCT03887273 — Phase 1 & 2
Transverse Myelitis Research Study Groups: Q-Cells dose level 1, Q-Cells dose level 2, Q-Cells dose level 3
Transverse Myelitis Clinical Trial 2023: Q-Cells® Highlights & Side Effects. Trial Name: NCT03887273 — Phase 1 & 2
Q-Cells® (Glial Progenitor Cells) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03887273 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this investigation available to participants under the age of 35?

"This medical study requires eligible participants to be between 18-70 years of age, as stipulated by the set inclusion criteria."

Answered by AI

Is this trial currently recruiting participants?

"According to clinicaltrials.gov, the trial is currently enrolling patients. The protocol was first published on September 20th 2022 and underwent its most recent update in August 17th of 2023."

Answered by AI

What is the current extent of participation in this clinical experiment?

"Affirmative, according to clinicaltrials.gov, this experiment is actively seeking volunteers for participation. The trial was posted on September 20th 2022 and updated most recently on August 17th 2023. Nine participants are expected to enroll at a single site of the study's operation."

Answered by AI

Is it possible for me to take part in this clinical research?

"This clinical trial is recruiting a total of 9 individuals between the ages 18 and 70 that have been diagnosed with idiopathic transverse myelitis in the past 120 months. Moreover, enrollees should be able to comprehend the risks associated with participating in this study, must live within reasonable distance from their designated medical centre or possess transportation arrangements, need to provide authorization for collection of PHI (Protected Health Information) as per local regulations, ought to have an available caregiver if needed during trials, require MRI imaging indicating single focus T2 hyperintensity 4-10 cm long or T1 post contrast enhancing lesion no larger than 10 cm"

Answered by AI

Who else is applying?

What site did they apply to?
UT Southwestern
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

Newly diagnosed TM, healthy, active 23 y/o female.
PatientReceived no prior treatments
~1 spots leftby Jul 2024