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Stem Cell Therapy

UCBMSC Transplant + Locomotor Training for Spinal Cord Injury

Phase 2
Waitlist Available
Research Sponsored by StemCyte International, Ltd.
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
Must not have
Subjects with flaccid paralysis with absence of deep tendon reflexes in the legs, severe atrophy of the lower limbs, or other evidence of lumbosacral injury, peripheral nerve injury, and motoneuronal loss
Unavailability of HLA-matched umbilical cord blood cells
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 2, 6, 28, and 48.
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have severe weakness or paralysis in my legs, significant muscle loss, or damage to my lower spine or nerves.
Select...
I do not have access to HLA-matched umbilical cord blood cells.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Walking Index of Spinal Cord Injury (WISCI II) Overall Measure
Secondary study objectives
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 study objectives
Exploratory Endpoint - Kunming Locomotor Score (KLS) Measure
Exploratory Endpoint - LANSS Scale Measure
Exploratory Endpoint - Long fiber bundles growth measure
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: MC001 before locomotor trainingExperimental Treatment2 Interventions
Transplant UCBMNC (MC001) first and then perform locomotor training
Group II: Locomotor training before MC001Experimental Treatment2 Interventions
Locomotor training first and then transplant UCBMNC (MC001)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Umbilical Cord Blood Mononuclear Cell
2010
Completed Phase 2
~30

Find a Location

Who is running the clinical trial?

StemCyte International, Ltd.Lead Sponsor
1 Previous Clinical Trials
39 Total Patients Enrolled
StemCyte, Inc.Industry 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 before locomotor training, Locomotor training before MC001
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
~7 spots leftby Aug 2026
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