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

Spinal Cord Injuries Clinical Trial

Official title:

Feasibility and Safety of Umbilical Cord Blood Cell Transplant Into Injured Spinal Cord: an Open-Labeled, Dose-Escalating Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01354483
• Other study ID #: CN102B_KM
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 14, 2011
• Last updated: August 20, 2014
• Start date: September 2011
• Est. completion date: December 2013

Study information

• Verified date: August 2014
• Source: China Spinal Cord Injury Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Cord Injuries

Intervention

Biological:
• Umbilical Cord Blood Mononuclear Cell

• Methylprednisolone
30mg/kg i.v. methylprednisolone

Drug:
• Lithium Carbonate Tablet
6 weeks

Locations

Country	Name	City	State
China	Treating Center of Spinal Cord Injury, Chengdu Army Kunming General Hospital	Kunming	Yunnan

Sponsors (2)

Lead Sponsor	Collaborator
China Spinal Cord Injury Network	Chengdu PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from Baseline in ASIA motor and sensory scores		Day 0, 3, Week 1, 2, 6, 14, 24, 48	Yes
Secondary	Spinal Cord Independence Measure (SCIM) score		Week 0, 2, 6, 14, 24, 48	Yes
Secondary	Walking Index of Spinal Cord Injury (WISCI) Level		Week 0, 2, 6, 14, 24 and 48	Yes
Secondary	Kunming Walking Score		Week 0, 2, 6, 14, 24, 48	Yes
Secondary	Modified Ashworth Scale (MAS)of spasticity		Day 0, 3, Week 1, 2, 6, 14, 24 48	Yes
Secondary	Visual Analog Scale of pain		Day 0, 3, Week 1, 2, 6, 14, 24, 48	Yes