Safety and Feasibility of Umbilical Cord Blood Cell Transplant Into Injured Spinal Cord

This study has been completed.
Sponsor:
Collaborators:
Chinese University of Hong Kong
The University of Hong Kong
Information provided by (Responsible Party):
China Spinal Cord Injury Network
ClinicalTrials.gov Identifier:
NCT01046786
First received: January 10, 2010
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

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
Drug: Methylprednisolone
Drug: Lithium
Phase 1
Phase 2

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • ASIA motor scores and sensory scores [ Time Frame: 0, 1, 2, 6 24 and 48 weeks ] [ Designated as safety issue: Yes ]
  • ASIA Impairment Scale grade [ Time Frame: 0, 1, 2, 6 24 and 48 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • MRI and Diffusion Tensor Imaging of spinal cord [ Time Frame: 0, 1, 24 and 48 weeks ] [ Designated as safety issue: Yes ]
  • Spinal Cord Independence Measure (SCIM) score [ Time Frame: 0, 6, 24 and 48 weeks ] [ Designated as safety issue: Yes ]
  • Walking Index of Spinal Cord Injury (WISCI) level [ Time Frame: 0, 6, 24 and 48 weeks ] [ Designated as safety issue: Yes ]
  • Modified Ashworth Scale (MAS) of Spasticity [ Time Frame: 0, 1, 2, 6, 24 and 48 weeks ] [ Designated as safety issue: Yes ]
  • Visual Analog Scale (VAS) of pain [ Time Frame: 0, 1, 2, 6, 24 and 48 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 8
Study Start Date: January 2010
Study Completion Date: December 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group A
Intraspinal injection of 1.6 million cord blood mononuclear cell
Biological: Umbilical Cord Blood Mononuclear Cell
The cord blood mononuclear cells are obtained from thawed units of HLA-matched human umbilical cord blood. The cells will be slowly injected into the posterior gray matter after laminectomy and opening of the dura.
Active Comparator: Group B
Intraspinal injection of 3.2 million cord blood mononuclear cell
Biological: Umbilical Cord Blood Mononuclear Cell
The cord blood mononuclear cells are obtained from thawed units of HLA-matched human umbilical cord blood. The cells will be slowly injected into the posterior gray matter after laminectomy and opening of the dura.
Active Comparator: Group C
Intraspinal injection of 6.4 million cord blood mononuclear cell
Biological: Umbilical Cord Blood Mononuclear Cell
The cord blood mononuclear cells are obtained from thawed units of HLA-matched human umbilical cord blood. The cells will be slowly injected into the posterior gray matter after laminectomy and opening of the dura.
Active Comparator: Group D
Intraspinal injection of 6.4 million cord blood mononuclear cell plus 30 mg/kg methylprednisolone
Biological: Umbilical Cord Blood Mononuclear Cell
The cord blood mononuclear cells are obtained from thawed units of HLA-matched human umbilical cord blood. The cells will be slowly injected into the posterior gray matter after laminectomy and opening of the dura.
Drug: Methylprednisolone
30 mg/kg methylprednisolone
Active Comparator: Group E
Intraspinal injection of 6.4 million cord blood mononuclear cell plus 30 mg/kg methylprednisolone plus 6 week course of oral lithium, titrated to maintain 0.6-1.0 mM serum level
Biological: Umbilical Cord Blood Mononuclear Cell
The cord blood mononuclear cells are obtained from thawed units of HLA-matched human umbilical cord blood. The cells will be slowly injected into the posterior gray matter after laminectomy and opening of the dura.
Drug: Methylprednisolone
30 mg/kg methylprednisolone
Drug: Lithium
oral lithium, titrated to maintain 0.6-1.0 mM serum level

Detailed Description:

This is an open-label, dose-escalating clinical trial. Three groups of four patients will receive transplants of increasing doses of HLA-matched umbilical cord blood mononuclear cell into the spinal cord. In the fourth group, we will transplant the highest volume of cells that did not increase neurological deficits along with a single bolus of 30mg/kg methylprednisolone sodium succinate. In the fifth group of four subjects, we will inject that volume of cells plus a bolus intravenous dose of 30mg/kg methylprednisolone sodium succinate and a 6-week course of oral lithium carbonate titrated to 0.6-1.0 mM serum levels. All the subjects are encouraged to stand or walk for one hour a day after the cell transplantation.

The neurological and walking outcomes will be assessed 1, 2, 6, 24 and 48 weeks after transplantation. The outcomes of the five treatment groups will be compared by analysis of variance and, if possible, correlation with cell dose. Efficacy and safety will be analyzed comparing neurological change scores amongst the five different treatment groups. Loss of motor (>5 points) or sensor scores (>2 points) from baseline pre-treatment levels would be considered deleterious. Increases in scores above baseline would be considered beneficial.

  Eligibility

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

Inclusion Criteria:

  • Subjects of either gender and 18-60 years old
  • Subjects with chronic spinal cord injury (defined as ≧12 months post-initial SCI surgery) with stable neurological findings for at least 6 months
  • Subject with a current neurological status of ASIA A
  • The neurological level of the subjects is between C5 and T11
  • The MRI shows that the injured site of the spinal cord is within three vertebral levels and there is no cyst
  • Subjects must be able to read, understand, and complete the Visual Analog Scale
  • Subjects who have voluntarily signed and dated an informed consent form, approved by the appropriate IRB, prior to any study-specific procedures

Exclusion Criteria:

  • Significant renal, cardiovascular, hepatic and psychiatric diseases
  • Significant medical diseases or infection (including but not limited to the carrier of hepatitis B virus or HIV)
  • Pregnant or lactating woman
  • Female of childbearing potential and who is unwilling to use an effective contraceptive method while enrolled in the study
  • The MRI shows that the length of spinal cord lesion exceeds three segments or there is cyst in the spinal cord
  • The lesion edge of the spinal cord cannot be determined by imaging technology
  • Unavailability of HLA matched umbilical cord blood cells
  • Any contraindication of laminectomy operation, MPSS and/or lithium carbonate
  • Subject who is currently participating in another investigational study or has been taking any investigational drug within the last 4 weeks prior to screening of this study and finally
  • Any 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 participant this 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: NCT01046786

Locations
Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Prince of Wales Hospital
Shatin, Hong Kong
Sponsors and Collaborators
China Spinal Cord Injury Network
Chinese University of Hong Kong
The University of Hong Kong
Investigators
Principal Investigator: Wai Sang Poon, MD The Chinese University of Hong Kong / Prince of Wales Hospital
Principal Investigator: Gilberto Leung, MD The University of Hong Kong / Queen Mary Hospital
  More Information

No publications provided

Responsible Party: China Spinal Cord Injury Network
ClinicalTrials.gov Identifier: NCT01046786     History of Changes
Other Study ID Numbers: CN102B
Study First Received: January 10, 2010
Last Updated: January 27, 2014
Health Authority: Hong Kong: Department of Health
Hong Kong: Ethics Committee
Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Keywords provided by China Spinal Cord Injury Network:
spinal cord injury
cord blood mononuclear cell
Methylprednisolone
Lithium Carbonate

Additional relevant MeSH terms:
Retinitis Pigmentosa
Spinal Cord Injuries
Central Nervous System Diseases
Eye Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn
Nervous System Diseases
Retinal Degeneration
Retinal Diseases
Retinal Dystrophies
Spinal Cord Diseases
Trauma, Nervous System
Wounds and Injuries
Lithium
Lithium Carbonate
Methylprednisolone
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antidepressive Agents
Antiemetics
Antimanic Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Antipsychotic Agents
Autonomic Agents

ClinicalTrials.gov processed this record on October 21, 2014