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Stem Cell Therapy

UCBMSC Transplant + Locomotor Training for Spinal Cord Injury

Phase 2

Recruiting

Research Sponsored by StemCyte, Inc.

Eligibility Criteria Checklist

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

Must have

Subjects with a current neurological status of ASIA impairment grade A (complete)

Traumatic SCI at a neurological level between C5 and T11 by MRI

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at week 2, 6, 28, and 48.

Awards & highlights

Study Summary

This trial is testing whether UCBMSCs can improve locomotor function in patients with chronic, stable and complete spinal cord injury.

Who is the study for?

This trial is for adults aged 18-60 with chronic, complete spinal cord injury between C5 and T11 levels, stable for at least six months. Participants must be able to stand using support for an hour daily and have a matched umbilical cord blood unit available. Excluded are those with significant medical conditions, active infections near the implant site, immune deficiencies, or severe bone density loss.Check my eligibility

What is being tested?

The study tests transplanting umbilical cord blood cells into the injured spinal cord followed by intensive locomotor training (walking exercises) up to five hours a day for three to six months. The goal is to assess improvement in patients with stable and complete spinal injuries.See study design

What are the potential side effects?

Potential side effects may include reactions from the stem cell transplant such as infection risks due to immune suppression and complications from surgery like bleeding or infection. Intensive walking exercises could lead to muscle soreness or fatigue.

Eligibility Criteria

Inclusion Criteria

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

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I have complete loss of motor and sensory function below the injury level.

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My spinal cord injury is between my neck and mid-back.

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I have a matched cord blood unit frozen for my treatment.

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My spinal cord injury is within three vertebrae of the site confirmed by an MRI.

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I am between 18 and 60 years old.

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I have moderate to severe problems with my organs not related to the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at week 2, 6, 28, and 48.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at week 2, 6, 28, and 48.

This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 2, 6, 28, and 48. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Walking Index of Spinal Cord Injury (WISCI II) Overall Measure

Secondary outcome measures

Measure of American Spinal Injury Association (ASIA) Motor and Sensory Scores and AIS Grade

Spinal Cord Independence Measure (SCIM III)

Walking Index of Spinal Cord Injury Measure (WISCI II) at Week 6 and 28

Other outcome measures

Exploratory Endpoint - Kunming Locomotor Score (KLS) Measure

Exploratory Endpoint - LANSS Scale Measure

Exploratory Endpoint - Long fiber bundles growth measure

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: No treatmentExperimental Treatment1 Intervention

No surgery, no transplant, locomotor training only

Group II: MC001Experimental Treatment2 Interventions

UCBMNC (MC001) transplant+Locomotor training

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Umbilical Cord Blood Mononuclear Cell

2010

Completed Phase 2

~30

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

StemCyte, Inc.Lead Sponsor

4 Previous Clinical Trials

64 Total Patients Enrolled

Media Library

Umbilical Cord Blood Mononuclear Cell (Stem Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03979742 — Phase 2

Spinal Cord Injury Research Study Groups: MC001, No treatment

Spinal Cord Injury Clinical Trial 2023: Umbilical Cord Blood Mononuclear Cell Highlights & Side Effects. Trial Name: NCT03979742 — Phase 2

Umbilical Cord Blood Mononuclear Cell (Stem Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03979742 — Phase 2

Frequently Asked Questions

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

Have any seniors been recruited to participate in this trial?

"Per the entry requirements of this scientific test, participants must be 18 years or older but not exceed 60 years."

Answered by AI

Are there vacancies for patient participation in this experiment?

"Affirmative. Clinicaltrials.gov's archives show that this clinical trial, which was posted on February 22nd 2022 is still attempting to recruit patients. A total of 18 participants are sought from 3 medical centres."

Answered by AI

What qualifications must participants possess to be accepted into this research?

"This clinical trial seeks 18 participants between the ages of eighteen and sixty with spinal cord injuries. To be eligible, applicants must meet numerous criteria: Male or female subjects aged from 18 to 60., Traumatic SCI injury at a neurological level ranging from C5 to T11 by MRI scan., The first three patients for each study centre should have thoracic region (between T1 and T11) as their neurological level of SCI., Subjects with chronic SCI (at least twelve months post-initial surgery), neurologically stable in the last six months who can stand up using support devices such as standing frame and tilt table for one hour"

Answered by AI

To what degree is Umbilical Cord Blood Mononuclear Cell safe for human consumption?

"Drawing from the available evidence, we can assign a score of 2 to Umbilical Cord Blood Mononuclear Cell's safety as it is currently in Phase 2 trials with some data regarding its safety but none yet related to efficacy."

Answered by AI

What is the utmost number of participants enrolling in this investigation?

"Affirmative, according to clinicaltrials.gov the trial is still calling for enrollees. It was initially made public on February 22nd of 2022 and has had an update as recently as May 13th. 18 individuals are being sought from 3 medical facilities."

Answered by AI