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Spinal Cord InjuriesPhase 1/2NCT01354483

Umbilical Cord Blood Mononuclear Cell Transplant to Treat Chronic Spinal Cord Injury

A Phase 1/2 study testing Umbilical Cord Blood Mononuclear Cell, Methylprednisolone and Lithium Carbonate Tablet in people with Spinal Cord Injuries, run by China Spinal Cord Injury Network at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to investigate the feasibility, safety, efficacy and optimal dose of umbilical cord blood mononuclear cell transplant in the treatment of chronic spinal cord injuries. 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, Methylprednisolone and Lithium Carbonate Tablet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
Sep 2011to Dec 2013
Phase
Phase 1/2
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

  • Subjects with chronic spinal cord injury (>12 months post-initial spinal cord injury surgery) with stable neurologic findings for at least 6 months
  • Subjects with current neurological status of ASIA A
  • The neurological level of the subjects is between C5 and T11
  • The injured site of the spinal cord is within three vertebral levels
  • Subjects must be able to read, understand, and complete the VAS
  • Subjects who have voluntarily signed and dated an informed consent form prior to any study procedures.

Who cannot join

  • Significant renal, cardiovascular, hepatic and psychiatric diseases
  • Significant medical diseases or infection
  • Pregnant or lactating woman
  • Female of childbearing potential and who is unwilling to use an effective contraceptive method while enrolled in the study
  • The length of spinal cord lesion exceeds three segments
  • Unavailability of HLA matched umbilical cord blood cells
Show all 9Show fewer
  • any contraindication of laminectomy operation, methylprednisolone and/or lithium carbonate
  • Subject who is currently participating in another investigational study or has been taking any investigation drug within the last 4 weeks prior to screening of the study
  • In opinion of the investigator, who suggests that the subject would not be compliant with the study protocol and/or would not be suitable to participate the study

Trial locations and contacts

1 site in 1 country.

China1 site

  • Treating Center of Spinal Cord Injury, Chengdu Army Kunming General Hospital

    Kunming, Yunnan, 650032

Other trials in China

About this study

Official title: Feasibility and Safety of Umbilical Cord Blood Cell Transplant Into Injured Spinal Cord: an Open-Labeled, Dose-Escalating Clinical Trial

The purpose of this study is to investigate the feasibility, safety, efficacy and optimal dose of umbilical cord blood mononuclear cell transplant in the treatment of chronic spinal cord injuries.

Read the detailed description

This is an open-label dose-escalating clinical trial. 20 patients will be randomly divided into 5 groups, 4 patient per group. The first three groups of four patients will receive transplants of increasing dose of HLA-matched umbilical cord blood mononuclear cells, starting from 4 spinal cord injection of 4µL of cell suspensions in Group A to 8µL in Group B and 16µL in Group C. If more than one subjects show neurological loss attributable to the cell injections, the trial will fall back to the previous dose. In the Group D, the highest volume of cells that do not cause neurological deficits (e.g. 16µL x4) along with a single bolus of 30 mg/kg methylprednisolone sodium succinate (MPSS) will be provided. Subjects in the Group E receive the same treatment as Group D plus a 6-week course of oral lithium carbonate. All subjects will enroll for three months intensive rehabilitation after the cell transplant.

Being tested
Umbilical Cord Blood Mononuclear Cell, Methylprednisolone, Lithium Carbonate Tablet
Keywords
spinal cord injury, umbilical cord blood mononuclear cell, lithium carbonate
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

  • MethylprednisoloneBiological

    30mg/kg i.v. methylprednisolone

  • Lithium Carbonate TabletDrug

    6 weeks

Study groups in NCT01354483
Study groupRoleWhat they receive
Treatment Group AExperimentalUmbilical cord blood mononuclear cell, 1.6 million
Receives: Biological: Umbilical Cord Blood Mononuclear Cell
Treatment Group BExperimentalUmbilical cord blood mononuclear cell, 3.2 million
Receives: Biological: Umbilical Cord Blood Mononuclear Cell
Treatment Group CExperimentalUmbilical cord blood mononuclear cell, 6.4 million
Receives: Biological: Umbilical Cord Blood Mononuclear Cell
Treatment Group DExperimentalUmbilical cord blood mononuclear cell, 6.4 million; mehtylprednisolone
Receives: Biological: Umbilical Cord Blood Mononuclear Cell; Biological: Methylprednisolone
Treatment Group EExperimentalUmbilical cord blood mononuclear cell, 6.4 million; methylprednisolone; 6 week course of lithium carbonate tablet
Receives: Biological: Umbilical Cord Blood Mononuclear Cell; Biological: Methylprednisolone; Drug: Lithium Carbonate Tablet

What is being measured

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

  1. Changes from Baseline in ASIA motor and sensory scores

    Measured: Day 0, 3, Week 1, 2, 6, 14, 24, 48

Secondary outcomes (5)

  1. Spinal Cord Independence Measure (SCIM) score

    Measured: Week 0, 2, 6, 14, 24, 48

  2. Walking Index of Spinal Cord Injury (WISCI) Level

    Measured: Week 0, 2, 6, 14, 24 and 48

  3. Kunming Walking Score

    Measured: Week 0, 2, 6, 14, 24, 48

  4. Modified Ashworth Scale (MAS)of spasticity

    Measured: Day 0, 3, Week 1, 2, 6, 14, 24 48

  5. Visual Analog Scale of pain

    Measured: Day 0, 3, Week 1, 2, 6, 14, 24, 48

Timeline

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

  1. First posted17 May 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionSep 2013
  4. Study completionDec 2013

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01354483
Sponsor's protocol ID
CN102B_KM
Status last verified
Aug 2014
First submitted
14 Feb 2011
Last updated
21 Aug 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Umbilical Cord Blood Mononuclear Cell, Methylprednisolone and Lithium Carbonate Tablet in people with Spinal Cord Injuries, run by China Spinal Cord Injury Network at 1 site in China.

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 6 inclusion and 9 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: finished, as of the sponsor's last update on 21 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Changes from Baseline in ASIA motor and sensory scores (time frame: Day 0, 3, Week 1, 2, 6, 14, 24, 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 NCT01354483.

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 21 Aug 2014.

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