Human Umbilical Cord Mesenchymal Stem Cell in Cerebral Hemorrhage Sequela

NCT02283879 | Unknown Phase 1 DMC

• 1 other identifier: HYK-Cerebral hemorrhage
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell(hUC-MSC) for cerebral hemorrhage sequela.

Conditions

Cerebral Hemorrhage

Keywords

Human Umbilical Cord Mesenchymal Stem Cell; Mesenchymal Stem Cell; Cerebral hemorrhage

Outcome Measures

Primary Outcomes (1)

• Safety evaluation through vital signs, the results of clinical lab tests and adverse events (AEs)

  12 months

Secondary Outcomes (3)

• Improvement of infarct size measured by brain MRI

  before the transplant and 1, 6, 12 months after transplantation

• Modified Barthel index

  before and 1, 3, 6 and 12 months after transplantation

• National Institutes of Health stroke scale(NIHSS) score

  before the transplant and after the transplant 1, 2 and 3 months

Study Arms (1)

hUC-MSC treatment

EXPERIMENTAL

Patients will receive human umbilical cord mesenchymal stem cells transplantation with a 12 months follow-up.

Biological: Human umbilical cord mesenchymal stem cells

Interventions

Human umbilical cord mesenchymal stem cells BIOLOGICAL

A single dose of 2×107 hUC-MSC will treated to patients, IV, Repeat every weeks for four times.

hUC-MSC treatment

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 40-70 intracerebral hemorrhage patient
• With stroke history of more than 3 months, less than 60 months
• National Institutes of Health stroke scale(NIHSS) score of 7 or more points
• Patient is stable (normal respiration, afebrile, BP less than mean arterial pressure of 125 mm of Hg, fasting blood sugar \<7 mg, and normal urea/electrolytes for at least 48 hours.)

You may not qualify if:

• History of neurological disease, head injury or psychiatric disorder;
• Pregnant women;
• Impaired liver function, abnormal blood coagulation, AIDS, HIV, combine other tumor or special condition;
• Progressive apoplexy;
• With malignant tumors.

Sponsors & Collaborators

• Shenzhen Hornetcorn Bio-technology Company, LTD: lead
• Fifth Affiliated Hospital of Guangzhou Medical University: collaborator

Study Sites (1)

The Fifth Affiliated Hospital Immunotherapy center

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ping J Chen, Professor

  Fifth Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2014
• First Posted: November 5, 2014
• Study Start: March 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: April 1, 2017
• Last Updated: May 24, 2016

Record last verified: 2015-07

Locations

CN (1)