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

NCT03979742 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: US105d
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Spinal Cord Injuries

Keywords

Spinal Cord Injury; Umbilical Cord Blood; Injured Spinal Cord; MC001

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (3)

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

  At Week 6 and 28.

• 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

  At Week 2, 6, 28, and 48.

Other Outcomes (5)

• Exploratory Endpoint - Kunming Locomotor Score (KLS) Measure

  At Week 6, 28, and 48.

• Exploratory Endpoint - Numerical Rating Scale (NRS) Measure

  At Week 2, 6, 28, and 48.

• Exploratory Endpoint - LANSS Scale Measure

  At Week 2, 6, 28, and 48.

Study Arms (2)

MC001 before locomotor training

EXPERIMENTAL

Transplant UCBMNC (MC001) first and then perform locomotor training

Biological: Umbilical Cord Blood Mononuclear Cell; Other: Locomotor Training

Locomotor training before MC001

EXPERIMENTAL

Locomotor training first and then transplant UCBMNC (MC001)

Biological: Umbilical Cord Blood Mononuclear Cell; Other: Locomotor Training

Interventions

Umbilical Cord Blood Mononuclear Cell BIOLOGICAL

Active ingredients: Monocytes, CD34+, CD133+ cells Dose: 4 injections of 16-μliter (100,000 cells/μliter)

Also known as: MC001

Locomotor training before MC001; MC001 before locomotor training

Locomotor Training OTHER

Locomotor training for up to 6 hours a day, 6 days a week, and for 3-6 months

Locomotor training before MC001; MC001 before locomotor training

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• StemCyte, Inc.: lead
• StemCyte Taiwan Co., Ltd.: collaborator

Study Sites (2)

Hualien Tzu Chi Hospital

Hualien City, Taiwan

Location

Taipei Medical University Hospital

Taipei, Taiwan

Location

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MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

MC001

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2019
• First Posted: June 7, 2019
• Study Start: February 22, 2022
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: February 28, 2025

Record last verified: 2025-02

Locations

TW (2)