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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
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
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 belowSelect...
I have complete loss of motor and sensory function below the injury level.
Select...
My spinal cord injury is between my neck and mid-back.
Select...
I have a matched cord blood unit frozen for my treatment.
Select...
My spinal cord injury is within three vertebrae of the site confirmed by an MRI.
Select...
I am between 18 and 60 years old.
Select...
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:Select...
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 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.
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 moreTrial 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
Find a Location
Who is running the clinical trial?
StemCyte, Inc.Lead Sponsor
4 Previous Clinical Trials
64 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have complete loss of motor and sensory function below the injury level.My spinal cord injury is between my neck and mid-back.My partner and I agree to use birth control.The investigator believes that you would not follow the study protocol or are not a good fit for this study.I am physically fit for surgery and can follow an intensive walking program.I do not have major health issues that could make surgery or intense physical training risky.I have a matched cord blood unit frozen for my treatment.I have had a spinal cord injury for over a year, with stable conditions for 6 months, and can stand for an hour daily with support.I do not have infections, severe spine deformity, immune issues, HIV, organ problems, depression, or low bone density.My spinal cord injury is within three vertebrae of the site confirmed by an MRI.Your heart's electrical activity, as shown in a test called an ECG, should be normal when you are resting. If it's not normal, the doctor in charge of the study will decide if it's not a big issue for this study.You have a serious spine deformity near the area where the implant will be placed.I had a fracture in my leg or hip, but it's healed.I have severe weakness or paralysis in my legs, significant muscle loss, or damage to my lower spine or nerves.I do not have any health conditions that could affect my treatment.I do not have access to HLA-matched umbilical cord blood cells.I am between 18 and 60 years old.I have an injury that could affect my ability to walk or my nerve function.I have moderate to severe problems with my organs not related to the study.
Research Study Groups:
This trial has the following groups:- Group 1: MC001
- Group 2: No treatment
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.
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