Umbilical Cord Blood Cell (MC001) Transplant Into Injured Spinal Cord Followed by the Locomotor Training

August 22, 2023 updated by: StemCyte, Inc.

A Randomized Controlled Phase II, Two-Arm Study of Umbilical Cord Blood Cell Transplant (MC001) Into Injured Spinal Cord Followed by the Locomotor Training for Patients With Chronic Complete Spinal Cord Injuries (SCI).

Umbilical cord blood mononuclear stem cells (UCBMSCs) transplant followed by the intensive locomotor training for up to 5±1 hours a day, 5±1 days a week, and for 3-6 months for treatment in patients with chronic, stable and complete spinal cord injury.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a randomized controlled, Phase II, two-arm study of Umbilical Cord Blood Mononuclear Cell (MC001) transplant into the injured spinal cord followed by the locomotor training for up to 5±1 hours a day, 5±1 days a week, for 3-6 months.

A total of 18 subjects with chronic complete spinal cord injury (SCI) will be randomized to one of the two groups. The subjects assigned to Group A will receive 6.4 million UCBMNC (MC001) transplanted into the dorsal root entry zones above and below the injury site exposed by a laminectomy. Subjects in Group B will not have MC001 transplant or surgery. All subjects will receive 3-6 months of intensive locomotor training.

Study Type

Interventional

Enrollment (Estimated)

18

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Hualien City, Taiwan
        • Recruiting
        • Hualien Tzu Chi Hospital
        • Contact:
          • Shinn-Zong Lin, MD, PhD
          • Phone Number: 886 975 661 719
      • Taipei City, Taiwan
        • Recruiting
        • Taipei Medical University Hospital
        • Contact:
          • Yung-Hsiao Chiang
          • Phone Number: 8016 886 2 27372181
  • United States
    • New Jersey
      • Montclair, New Jersey, United States, 07042
        • Not yet recruiting
        • Mountainside Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male and female subjects' ≥18 to ≤60 years.
  • Traumatic SCI at a neurological level (the lowest contiguous spinal cord segmental level that has intact motor and sensory score) between C5 and T11 by MRI.

Note: For the first three subjects at each study center, the neurological level of SCI will be limited to thoracic region (between T1 and T11).

  • Subjects with chronic SCI (defined as ≥ 12 months post- initial SCI surgery) with stable neurologic findings for at least six months and be able stand at least 1 hour/day using a standing frame, tilt table, or equivalent device.
  • Subjects with a current neurological status of ASIA impairment grade A (complete).
  • The injured site of the spinal cord is within three vertebral levels as confirmed by MRI scan.
  • Subject must be in good enough physical health to tolerate the surgery and participate in the intensive walking program.
  • Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.
  • Both male and female subjects and their partners of childbearing potential must agree to use medically accepted methods of contraception.
  • Willing and able to participate in all aspects of the study, including completion of subjective evaluations, attendance at scheduled clinic visits, and compliance with all protocol requirements as evidenced by providing written informed consent.
  • At least one frozen HLA-matched (≥4:6 to a specific patient) CBU identified for each subject.

Exclusion Criteria:

  • Clinically significant renal, cardiovascular, hepatic and psychiatric diseases or other conditions that may increase risk of complications during or after surgery or may reduce the ability of the patient to participate in intense locomotor training based on the medical judgment of the investigator.
  • Presence of any clinically significant medical condition(s) or infection (including but not limited to the carrier of hepatitis B virus or HIV) that, in the opinion of the Investigator, could interfere with the treatment or participation in the study.
  • 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.
  • Fracture of weight-bearing bones and joints. These include fractures of femur, tibia, and fibula, as well as the ankle, knee, or hip joints. If such fractures have healed, the patient can be included in the trial.
  • Injury to brain, peripheral nerve, or muscle that may interfere with neurologic or walking assessment.
  • Pregnant or lactating woman.
  • Unavailability of HLA-matched umbilical cord blood cells.

  • Any contraindication of laminectomy operation or locomotor training includes:

    • Patient with active infection diseases.
    • Patient with wound infection on or near the implantation site.
    • Patient with severe deformity of spine on or near the implantation site.
    • Patient has immuno-compromised condition, or is with known autoimmune conditions or is human immunodeficiency virus (HIV) seropositive.
    • Patient has on-going moderate to severe organ impairment other than study.
  • Subject with abnormal renal function, cardiovascular disease, depression at screening will be excluded, if considered clinically significant and unstable by the Principal Investigator.
  • Subject who is currently participating in another investigational study or has been taking any investigational drug within the last 4 weeks before screening for this study.
  • Any other criteria, which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol and/or would not be suitable to participate in this study.
  • Subject with low bone density (DEXA scan resulted T score < -4).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MC001
UCBMNC (MC001) transplant+Locomotor training
Biological: Umbilical Cord Blood Mononuclear Cell
Active ingredients: Monocytes, CD34+, CD133+ cells Dose: 4 injections of 16-μliter (100,000 cells/μliter)
Other Names:
  • MC001
Other: Locomotor Training
Locomotor training for up to 6 hours a day, 6 days a week, and for 3-6 months
Other: No treatment
No surgery, no transplant, locomotor training only
Other: Locomotor Training
Locomotor training for up to 6 hours a day, 6 days a week, and for 3-6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Walking Index of Spinal Cord Injury (WISCI II) Overall Measure
Time Frame: At Week 48.
The primary endpoint for this study is mean change from baseline of the Walking Index of Spinal Cord Injury (WISCI II).
At Week 48.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Walking Index of Spinal Cord Injury Measure (WISCI II) at Week 6 and 28
Time Frame: At Week 6 and 28.
Mean change from baseline of the Walking Index of Spinal Cord Injury (WISCI II).
At Week 6 and 28.
Spinal Cord Independence Measure (SCIM III)
Time Frame: At Week 6, 28, and 48.
Mean change from baseline of Spinal Cord Independence Measure (SCIM III)
At Week 6, 28, and 48.
Measure of American Spinal Injury Association (ASIA) Motor and Sensory Scores and AIS Grade
Time Frame: At Week 2, 6, 28, and 48.
American Spinal Injury Association (ASIA) score has three components: (1) Sensory scores: There is a maximum total of 56 points each for light touch and pin prick (sharp/dull discrimination) modalities, for a total of 112 points per side of the body. (2) Motor scores: There is a maximum score of 25 for each extremity, totaling 50 for the upper limbs and 50 for the lower limbs. (3) ASIA Impairment Scale: Injuries are classified in general terms of being neurologically "complete" or "incomplete" based upon the sacral sparing definition.
At Week 2, 6, 28, and 48.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploratory Endpoint - Kunming Locomotor Score (KLS) Measure
Time Frame: At Week 6, 28, and 48.
Mean change from baseline of Kunming locomotor scores (KLS). Kunming Locomotor Scale (KLS) is a 10-grade Roman numeral locomotion scoring system describing ability to stand, ability to walk, and required support/devices.
At Week 6, 28, and 48.
Exploratory Endpoint - Numerical Rating Scale (NRS) Measure
Time Frame: At Week 2, 6, 28, and 48.
Mean change from baseline of Numerical Rating Scale (NRS) for neuropathic pain. An 11-unit scale will be used, where 0 represents "No pain" and 10 represents the "Worst possible pain".
At Week 2, 6, 28, and 48.
Exploratory Endpoint - LANSS Scale Measure
Time Frame: At Week 2, 6, 28, and 48.

Mean change from baseline of Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) scale. An 11-unit scale will be used, where 0 represents "No pain" and 10 represents the "Worst possible pain".

The Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) pain scale is an assessment tool used to analyze and classify pain. It is a simple bedside test, conducted in two parts .i.e. a patient-completed questionnaire and a brief clinical assessment. Out of the seven items in the LANSS Pain Scale, five are symptom related and two are examination items.
At Week 2, 6, 28, and 48.
Exploratory Endpoint - SSEP and MEP Measure
Time Frame: At week 48.
Percentage of subjects with positive change in Somatosensory evoked potential (SSEP) and Motor evoked potentials (MEP).
At week 48.
Exploratory Endpoint - Long fiber bundles growth measure
Time Frame: At Week 6, 28, and 48.
Percentage of subjects with Long fiber bundles growth crossing the injury site by Magnetic resonance diffusion tenor images (MR/DTI).
At Week 6, 28, and 48.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

StemCyte, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2022

Primary Completion (Estimated)

August 22, 2026

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

June 3, 2019

First Submitted That Met QC Criteria

June 6, 2019

First Posted (Actual)

June 7, 2019

Study Record Updates

Last Update Posted (Actual)

August 24, 2023

Last Update Submitted That Met QC Criteria

August 22, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • US105d

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

All information supplied by StemCyte, Inc in connection with this study and not previously published, is considered confidential information. This information includes, but is not limited to, the Investigator's Brochure, clinical protocol, case report forms and other scientific data. All data collected during the study are confidential. This confidential information shall remain the sole property of StemCyte, Inc, shall not be disclosed to others without the written consent of StemCyte, Inc, and shall not be used except in the performance of this study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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