Umbilical Cord Blood Mononuclear Cell Transplant to Treat Chronic Spinal Cord Injury - Full Text View

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: Umbilical Cord Blood Mononuclear Cell, Methylprednisolone Biological: Umbilical Cord Blood Mononuclear Cell, Methylprednisolone, Lithium Carbonate	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:

Genetics Home Reference related topics: Lenz microphthalmia syndrome oculofaciocardiodental syndrome Peters plus syndrome retinitis pigmentosa X-linked juvenile retinoschisis

MedlinePlus related topics: Spinal Cord Injuries

Drug Information available for: Prednisolone Prednisolone acetate Methylprednisolone acetate Methylprednisolone Prednisolone sodium phosphate Prednisolone phosphate Lithium carbonate Prednisolone sodium succinate Methylprednisolone sodium succinate Lithium citrate

U.S. FDA Resources

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
Estimated Study Completion Date:	September 2013
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Treatment Group A	Biological: Umbilical Cord Blood Mononuclear Cell Intraspinal injection of 1.6 million cells
Experimental: Treatment Group B	Biological: Umbilical Cord Blood Mononuclear Cell Intraspinal injection of 3.2 million cells
Experimental: Treatment Group C	Biological: Umbilical Cord Blood Mononuclear Cell Intraspinal injection of 6.4 million cells
Experimental: Treatment Group D	Biological: Umbilical Cord Blood Mononuclear Cell, Methylprednisolone Intraspinal injection of 6.4 million cells (or highest dose without deficit), plus 30mg/kg i.v. methylprednisolone
Experimental: Treatment Group E	Biological: Umbilical Cord Blood Mononuclear Cell, Methylprednisolone, Lithium Carbonate Intraspinal injection of 6.4 million cells, plus methyprednisolone, plus 6-week course of oral lithium carbonate

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

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:	May 12, 2013
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
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 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 May 19, 2013