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Spinal Cord InjuriesPhase 2NCT03979742

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

A Phase 2 study testing Umbilical Cord Blood Mononuclear Cell and Locomotor Training in people with Spinal Cord Injuries, run by StemCyte, Inc. at 2 sites in Taiwan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Spinal Cord Injuries
What is being tested?
Umbilical Cord Blood Mononuclear Cell and Locomotor Training
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
2 sitesTaiwan
Study dates
22 Feb 2022to 30 Dec 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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).

Trial locations and contacts

2 sites in 1 country.

Taiwan2 sites

  • Hualien Tzu Chi Hospital

    Hualien City

  • Taipei Medical University Hospital

    Taipei

Other trials in Taiwan

About this study

Official title: 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.

Read the 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.

Being tested
Umbilical Cord Blood Mononuclear Cell, Locomotor Training
Keywords
Spinal Cord Injury, Umbilical Cord Blood, Injured Spinal Cord, MC001
Medical subject headings
Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Umbilical Cord Blood Mononuclear CellBiological

    Also called MC001

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

  • Locomotor TrainingOther

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

Study groups in NCT03979742
Study groupRoleWhat they receive
MC001 before locomotor trainingExperimentalTransplant UCBMNC (MC001) first and then perform locomotor training
Receives: Biological: Umbilical Cord Blood Mononuclear Cell; Other: Locomotor Training
Locomotor training before MC001ExperimentalLocomotor training first and then transplant UCBMNC (MC001)
Receives: Biological: Umbilical Cord Blood Mononuclear Cell; Other: Locomotor Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: At Week 48.

Secondary outcomes (3)

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

    Mean change from baseline of the Walking Index of Spinal Cord Injury (WISCI II).

    Measured: At Week 6 and 28.

  2. Spinal Cord Independence Measure (SCIM III)

    Mean change from baseline of Spinal Cord Independence Measure (SCIM III)

    Measured: At Week 6, 28, and 48.

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

    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.

    Measured: At Week 2, 6, 28, and 48.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2019
  2. Study start22 Feb 2022
  3. Primary completion30 Dec 2024
  4. Study completion30 Dec 2024

Why it stopped: business strategic consideration

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03979742
Sponsor's protocol ID
US105d
Status last verified
Feb 2025
First submitted
3 Jun 2019
Last updated
28 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided: 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.

Publications

  • Ackery A, Tator C, Krassioukov A. A global perspective on spinal cord injury epidemiology. J Neurotrauma. 2004 Oct;21(10):1355-70. doi: 10.1089/neu.2004.21.1355.

    PubMed 15672627

  • Aleksic D, Aksic M, Divac N, Radonjic V, Filipovic B, Jakovcevski I. Thermomineral water promotes axonal sprouting but does not reduce glial scar formation in a mouse model of spinal cord injury. Neural Regen Res. 2014 Dec 15;9(24):2174-81. doi: 10.4103/1673-5374.147950.

    PubMed 25657739

  • Angelucci F, Mathe AA, Aloe L. Neurotrophic factors and CNS disorders: findings in rodent models of depression and schizophrenia. Prog Brain Res. 2004;146:151-65. doi: 10.1016/s0079-6123(03)46011-1.

    PubMed 14699963

  • Aubert J, Dunstan H, Chambers I, Smith A. Functional gene screening in embryonic stem cells implicates Wnt antagonism in neural differentiation. Nat Biotechnol. 2002 Dec;20(12):1240-5. doi: 10.1038/nbt763. Epub 2002 Nov 25.

    PubMed 12447396

  • Banafshe HR, Mesdaghinia A, Arani MN, Ramezani MH, Heydari A, Hamidi GA. Lithium attenuates pain-related behavior in a rat model of neuropathic pain: possible involvement of opioid system. Pharmacol Biochem Behav. 2012 Jan;100(3):425-30. doi: 10.1016/j.pbb.2011.10.004. Epub 2011 Oct 8.

    PubMed 22009032

  • Boku S, Nakagawa S, Koyama T. Glucocorticoids and lithium in adult hippocampal neurogenesis. Vitam Horm. 2010;82:421-31. doi: 10.1016/S0083-6729(10)82021-7.

    PubMed 20472150

  • Butler MG, Menitove JE. Umbilical cord blood banking: an update. J Assist Reprod Genet. 2011 Aug;28(8):669-76. doi: 10.1007/s10815-011-9577-x. Epub 2011 May 27.

    PubMed 21617932

  • Cabrera O, Dougherty J, Singh S, Swiney BS, Farber NB, Noguchi KK. Lithium protects against glucocorticoid induced neural progenitor cell apoptosis in the developing cerebellum. Brain Res. 2014 Jan 30;1545:54-63. doi: 10.1016/j.brainres.2013.12.014. Epub 2013 Dec 19.

    PubMed 24361977

  • Cao FJ, Feng SQ. Human umbilical cord mesenchymal stem cells and the treatment of spinal cord injury. Chin Med J (Engl). 2009 Jan 20;122(2):225-31.

    PubMed 19187651

  • Chen CT, Foo NH, Liu WS, Chen SH. Infusion of human umbilical cord blood cells ameliorates hind limb dysfunction in experimental spinal cord injury through anti-inflammatory, vasculogenic and neurotrophic mechanisms. Pediatr Neonatol. 2008 Jun;49(3):77-83. doi: 10.1016/S1875-9572(08)60017-0.

    PubMed 18947003

  • Childers WE Jr, Baudy RB. N-methyl-D-aspartate antagonists and neuropathic pain: the search for relief. J Med Chem. 2007 May 31;50(11):2557-62. doi: 10.1021/jm060728b. Epub 2007 May 10. No abstract available.

    PubMed 17489572

  • Cho SR, Yang MS, Yim SH, Park JH, Lee JE, Eom YW, Jang IK, Kim HE, Park JS, Kim HO, Lee BH, Park CI, Kim YJ. Neurally induced umbilical cord blood cells modestly repair injured spinal cords. Neuroreport. 2008 Aug 27;19(13):1259-63. doi: 10.1097/WNR.0b013e3283089234.

    PubMed 18695504

  • Chua SJ, Bielecki R, Yamanaka N, Fehlings MG, Rogers IM, Casper RF. The effect of umbilical cord blood cells on outcomes after experimental traumatic spinal cord injury. Spine (Phila Pa 1976). 2010 Jul 15;35(16):1520-6. doi: 10.1097/BRS.0b013e3181c3e963.

    PubMed 20581748

  • Chung HJ, Chung WH, Lee JH, Chung DJ, Yang WJ, Lee AJ, Choi CB, Chang HS, Kim DH, Suh HJ, Lee DH, Hwang SH, Do SH, Kim HY. Expression of neurotrophic factors in injured spinal cord after transplantation of human-umbilical cord blood stem cells in rats. J Vet Sci. 2016 Mar;17(1):97-102. doi: 10.4142/jvs.2016.17.1.97. Epub 2016 Mar 22.

    PubMed 27051345

  • Chung WH, Park SA, Lee JH, Chung DJ, Yang WJ, Kang EH, Choi CB, Chang HS, Kim DH, Hwang SH, Han H, Kim HY. Percutaneous transplantation of human umbilical cord-derived mesenchymal stem cells in a dog suspected to have fibrocartilaginous embolic myelopathy. J Vet Sci. 2013;14(4):495-7. doi: 10.4142/jvs.2013.14.4.495. Epub 2013 Jun 28.

    PubMed 23820160

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Umbilical Cord Blood Mononuclear Cell and Locomotor Training in people with Spinal Cord Injuries, run by StemCyte, Inc. at 2 sites in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: business strategic consideration). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Walking Index of Spinal Cord Injury (WISCI II) Overall Measure (time frame: At Week 48.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03979742, which also lists 90 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.

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