Safety and Feasibility of Umbilical Cord Blood Cell Transplant Into Injured Spinal Cord - Full Text View

Sponsor:	China Spinal Cord Injury Network
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

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:

Genetics Home Reference related topics: X-linked juvenile retinoschisis Help Me Understand Genetics

MedlinePlus related topics: Spinal Cord Injuries

Drug Information available for: Prednisolone Prednisolone acetate Methylprednisolone acetate Methylprednisolone Prednisolone Sodium Phosphate Prednisolone phosphate Lithium carbonate Methylprednisolone Sodium Succinate Lithium citrate

U.S. FDA Resources

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 ]

Estimated Enrollment:	20
Study Start Date:	January 2010
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	September 2012 (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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01046786

Locations

Hong Kong
Queen Mary Hospital	Recruiting
Hong Kong, Hong Kong
Contact: Gilberto Leung, MD +852 2255 4181 gilberto@hkucc.hku.hk
Principal Investigator: Gilberto Leung, MD
Sub-Investigator: Yatwa Wong, MD
Prince of Wales Hospital	Recruiting
Shatin, Hong Kong
Contact: Wai Sang Poon, MD +852 2632 1625 sci-study@surgery.cuhk.edu.hk
Principal Investigator: Wai Sang Poon, MD

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:	April 12, 2012
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
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
Wounds and Injuries
Lithium
Lithium Carbonate

Methylprednisolone
Methylprednisolone Hemisuccinate
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Prednisolone phosphate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Antimanic Agents

ClinicalTrials.gov processed this record on May 23, 2012