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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
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 belowSelect...
I am between 18 and 70 years old.
Select...
My MRI shows a specific type of abnormal area in my spine that is 4 to 10 cm long.
Select...
I will use effective birth control during and up to one year after the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 9-months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9-months
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 moreTrial 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
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Who is running the clinical trial?
Q Therapeutics, Inc.Lead Sponsor
1 Previous Clinical Trials
30 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I am between 18 and 70 years old.Your AST or ALT levels are more than 3 times the normal limit.Your blood pressure is very high and not well controlled.You have pre-existing antibodies against Q-Cells® as shown by a specific blood test.I have a history of blood clots.I do not have conditions like severe nerve pain or muscle diseases that affect my movement.I do not have any major health issues that would make surgery risky for me.I have had deep vein thrombosis confirmed by an ultrasound.I don't have any health conditions that make surgery too risky.I have been diagnosed with a neurodegenerative disease like ALS, Parkinson's, or Alzheimer's.Your lab test results at the screening visit show significant abnormalities, as determined by the doctor.My kidney function is reduced, with a filtration rate below 60 mL/min.I was diagnosed with idiopathic transverse myelitis within the last 10 years.I have had a stem cell transplant in the past.I have someone to help me with travel and care for my study needs.I have severe spinal narrowing or pressure on my spinal cord causing nerve issues.It has been over a year since my TM symptoms started.Your brain MRI does not show signs of multiple sclerosis or other similar diseases.You have a serious problem with memory or thinking, or a major psychiatric illness like severe depression or bipolar disorder.You have had problems with alcohol or drug abuse or dependence in the past year, according to specific criteria.I have diabetes or my HgbA1c level is above 6.5.You have the lowest level of spinal cord injury according to the ASIA scale.My neurological symptoms from TM have been stable for 3 months.I have had spine surgery or a unique spine structure that may affect treatment.I don't have conditions or take medications that conflict with tacrolimus, mycophenolate mofetil, or prednisone.I am not immune compromised and do not have conditions like TB that prevent immunosuppression treatment.My MRI shows a specific type of abnormal area in my spine that is 4 to 10 cm long.You have not been checked for other conditions that can cause weakness, sensory loss, or autonomic dysfunction besides transverse myelitis.I have not received a live virus vaccine in the last 6 weeks.I have had stomach bleeding or ulcers in the past year or am being treated to prevent them.I do not have any brain or spinal cord tumors.I have had optic neuritis.I can travel to the center easily or have a reliable way to get there.You tested negative for NMO IgG (anti-AQP4) two times, with at least 6 months between each test.I will use effective birth control during and up to one year after the study.I am physically and medically able to follow the study's procedures and visit schedule.
Research Study Groups:
This trial has the following groups:- Group 1: Q-Cells dose level 1
- Group 2: Q-Cells dose level 2
- Group 3: Q-Cells dose level 3
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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