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

This study has been completed.
Sponsor:
Collaborator:
Chengdu PLA General Hospital
Information provided by (Responsible Party):
China Spinal Cord Injury Network
ClinicalTrials.gov Identifier:
NCT01354483
First received: February 14, 2011
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Spinal Cord Injuries
Biological: Umbilical Cord Blood Mononuclear Cell
Biological: Methylprednisolone
Drug: Lithium Carbonate Tablet
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility and Safety of Umbilical Cord Blood Cell Transplant Into Injured Spinal Cord: an Open-Labeled, Dose-Escalating Clinical Trial

Resource links provided by NLM:


Further study details as provided by China Spinal Cord Injury Network:

Primary Outcome Measures:
  • Changes from Baseline in ASIA motor and sensory scores [ Time Frame: Day 0, 3, Week 1, 2, 6, 14, 24, 48 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Spinal Cord Independence Measure (SCIM) score [ Time Frame: Week 0, 2, 6, 14, 24, 48 ] [ Designated as safety issue: Yes ]
  • Walking Index of Spinal Cord Injury (WISCI) Level [ Time Frame: Week 0, 2, 6, 14, 24 and 48 ] [ Designated as safety issue: Yes ]
  • Kunming Walking Score [ Time Frame: Week 0, 2, 6, 14, 24, 48 ] [ Designated as safety issue: Yes ]
  • Modified Ashworth Scale (MAS)of spasticity [ Time Frame: Day 0, 3, Week 1, 2, 6, 14, 24 48 ] [ Designated as safety issue: Yes ]
  • Visual Analog Scale of pain [ Time Frame: Day 0, 3, Week 1, 2, 6, 14, 24, 48 ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: September 2010
Study Completion Date: December 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Group A
Umbilical cord blood mononuclear cell, 1.6 million
Biological: Umbilical Cord Blood Mononuclear Cell
Experimental: Treatment Group B
Umbilical cord blood mononuclear cell, 3.2 million
Biological: Umbilical Cord Blood Mononuclear Cell
Experimental: Treatment Group C
Umbilical cord blood mononuclear cell, 6.4 million
Biological: Umbilical Cord Blood Mononuclear Cell
Experimental: Treatment Group D
Umbilical cord blood mononuclear cell, 6.4 million; mehtylprednisolone
Biological: Umbilical Cord Blood Mononuclear Cell Biological: Methylprednisolone
30mg/kg i.v. methylprednisolone
Experimental: Treatment Group E
Umbilical cord blood mononuclear cell, 6.4 million; methylprednisolone; 6 week course of lithium carbonate tablet
Biological: Umbilical Cord Blood Mononuclear Cell Biological: Methylprednisolone
30mg/kg i.v. methylprednisolone
Drug: Lithium Carbonate Tablet
6 weeks

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01354483

Locations
China, Yunnan
Treating Center of Spinal Cord Injury, Chengdu Army Kunming General Hospital
Kunming, Yunnan, China, 650032
Sponsors and Collaborators
China Spinal Cord Injury Network
Chengdu PLA General Hospital
Investigators
Principal Investigator: Hui Zhu, MD Chengdu PLA General Hospital
  More Information

No publications provided

Responsible Party: China Spinal Cord Injury Network
ClinicalTrials.gov Identifier: NCT01354483     History of Changes
Other Study ID Numbers: CN102B_KM
Study First Received: February 14, 2011
Last Updated: January 27, 2014
Health Authority: China: Ethics Committee

Keywords provided by China Spinal Cord Injury Network:
spinal cord injury
umbilical cord blood mononuclear cell
lithium carbonate

Additional relevant MeSH terms:
Retinitis Pigmentosa
Spinal Cord Injuries
Wounds and Injuries
Eye Diseases, Hereditary
Eye Diseases
Retinal Dystrophies
Retinal Degeneration
Retinal Diseases
Genetic Diseases, Inborn
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Lithium
Lithium Carbonate
Methylprednisolone
Methylprednisolone Hemisuccinate
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on July 22, 2014