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

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01046786
• Other study ID #: CN102B
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 10, 2010
• Last updated: January 27, 2014
• Start date: January 2010
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: China Spinal Cord Injury Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Department of HealthHong Kong: Ethics CommitteeHong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: December 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Spinal Cord Injuries

Intervention

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
• Lithium
oral lithium, titrated to maintain 0.6-1.0 mM serum level

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital	Hong Kong
Hong Kong	Prince of Wales Hospital	Shatin

Sponsors (3)

Lead Sponsor	Collaborator
China Spinal Cord Injury Network	Chinese University of Hong Kong, The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ASIA motor scores and sensory scores		0, 1, 2, 6 24 and 48 weeks	Yes
Primary	ASIA Impairment Scale grade		0, 1, 2, 6 24 and 48 weeks	Yes
Secondary	MRI and Diffusion Tensor Imaging of spinal cord		0, 1, 24 and 48 weeks	Yes
Secondary	Spinal Cord Independence Measure (SCIM) score		0, 6, 24 and 48 weeks	Yes
Secondary	Walking Index of Spinal Cord Injury (WISCI) level		0, 6, 24 and 48 weeks	Yes
Secondary	Modified Ashworth Scale (MAS) of Spasticity		0, 1, 2, 6, 24 and 48 weeks	Yes
Secondary	Visual Analog Scale (VAS) of pain		0, 1, 2, 6, 24 and 48 weeks	Yes