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

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.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Biological: Umbilical Cord Blood Mononuclear Cell; Biological: Methylprednisolone; Drug: Lithium Carbonate Tablet

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Yunnan
    • Kunming, Yunnan, China, 650032
      • Treating Center of Spinal Cord Injury, Chengdu Army Kunming General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes from Baseline in ASIA motor and sensory scores	Day 0, 3, Week 1, 2, 6, 14, 24, 48

Secondary Outcome Measures

Outcome Measure	Time Frame
Spinal Cord Independence Measure (SCIM) score	Week 0, 2, 6, 14, 24, 48
Walking Index of Spinal Cord Injury (WISCI) Level	Week 0, 2, 6, 14, 24 and 48
Kunming Walking Score	Week 0, 2, 6, 14, 24, 48
Modified Ashworth Scale (MAS)of spasticity	Day 0, 3, Week 1, 2, 6, 14, 24 48
Visual Analog Scale of pain	Day 0, 3, Week 1, 2, 6, 14, 24, 48

Collaborators and Investigators

• Sponsor: China Spinal Cord Injury Network
• Collaborators: Chengdu PLA General Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: February 14, 2011
• First Submitted That Met QC Criteria: May 16, 2011
• First Posted (Estimate): May 17, 2011

Study Record Updates

• Last Update Posted (Estimate): August 21, 2014
• Last Update Submitted That Met QC Criteria: August 20, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: spinal cord injury; lithium carbonate; umbilical cord blood mononuclear cell
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Tranquilizing Agents; Psychotropic Drugs; Antidepressive Agents; Antimanic Agents; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Lithium Carbonate
• Other Study ID Numbers: CN102B_KM