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

NCT01046786 | Completed Phase 1 DMC

• 1 other identifier: CN102B
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Spinal Cord Injuries

Keywords

spinal cord injury; cord blood mononuclear cell; Methylprednisolone; Lithium Carbonate

Outcome Measures

Primary Outcomes (2)

• ASIA motor scores and sensory scores

  0, 1, 2, 6 24 and 48 weeks

• ASIA Impairment Scale grade

  0, 1, 2, 6 24 and 48 weeks

Secondary Outcomes (5)

• MRI and Diffusion Tensor Imaging of spinal cord

  0, 1, 24 and 48 weeks

• Spinal Cord Independence Measure (SCIM) score

  0, 6, 24 and 48 weeks

• Walking Index of Spinal Cord Injury (WISCI) level

  0, 6, 24 and 48 weeks

• Modified Ashworth Scale (MAS) of Spasticity

  0, 1, 2, 6, 24 and 48 weeks

• Visual Analog Scale (VAS) of pain

  0, 1, 2, 6, 24 and 48 weeks

Study Arms (5)

Group A

ACTIVE COMPARATOR

Intraspinal injection of 1.6 million cord blood mononuclear cell

Biological: Umbilical Cord Blood Mononuclear Cell

Group B

ACTIVE COMPARATOR

Intraspinal injection of 3.2 million cord blood mononuclear cell

Biological: Umbilical Cord Blood Mononuclear Cell

Group C

ACTIVE COMPARATOR

Intraspinal injection of 6.4 million cord blood mononuclear cell

Biological: Umbilical Cord Blood Mononuclear Cell

Group D

ACTIVE COMPARATOR

Intraspinal injection of 6.4 million cord blood mononuclear cell plus 30 mg/kg methylprednisolone

Biological: Umbilical Cord Blood Mononuclear Cell; Drug: Methylprednisolone

Group E

ACTIVE COMPARATOR

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; Drug: Methylprednisolone; Drug: Lithium

Interventions

Umbilical Cord Blood Mononuclear Cell BIOLOGICAL

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.

Group A; Group B; Group C; Group D; Group E

Methylprednisolone DRUG

30 mg/kg methylprednisolone

Group D; Group E

Lithium DRUG

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

Group E

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• China Spinal Cord Injury Network: lead
• Chinese University of Hong Kong: collaborator
• The University of Hong Kong: collaborator

Study Sites (2)

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Prince of Wales Hospital

Shatin, Hong Kong

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Methylprednisolone; Lithium

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Metals, Alkali; Elements; Inorganic Chemicals; Metals, Light; Metals

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2010
• First Posted: January 12, 2010
• Study Start: January 1, 2010
• Primary Completion: October 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 28, 2014

Record last verified: 2014-01

Locations

HK (2)