The Clinical Trial Research of Stem Cell Transplantation Treats Cerebral

NCT01389453 | Withdrawn Phase 2 DMC

• 1 other identifier: 2011-04-17 stroke
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

All experimental group patients of 100 patients accept a treatment course stem cell transplantation, including one time stem cell transplantation through intravenous injection way at the 10-21th day of cerebral hemorrhage, and the 7-14th day of cerebral infarction incidence; the second time transplantation through lumbar puncture way at the 7th day after the First time transplantation. The control group gives injection through intravenous and lumbar puncture ways separately in the corresponding time, but the transplantation matter is physiological saline not the stem cell.

Conditions

Stroke

Keywords

umbilical cord mesenchyma stem cell transplantation

Outcome Measures

Primary Outcomes (1)

• NIHSS and FIM

  All patients should receive the American State-run Health Research institute apoplexy meter (NIHSS)evaluation, the Fugl-Meyer evaluation, the function independence evaluation (FIM) separately before the transplant and after the transplant 1, 2 and 3 months , and the grading has the distinct improvement;

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

Secondary Outcomes (2)

• Motor evoked potential and sensation evoked potential inspection

  before the transplant and after the transplant 0, 1, 3, 6 and 12 months

• MRI+ DWI+ enhancement scanning

  before the transplant and after the transplant 0, 1, 3, 6 and 12 months

Study Arms (2)

stem cell transplatation

ACTIVE COMPARATOR

All experimental group patients accept a treatment course stem cell transplantation, including one time stem cell transplantation through intravenous injection way at the 10-21th day of cerebral hemorrhage, and the 7-14th day of cerebral infarction incidence; the second time transplantation through lumbar puncture way at the 7th day after the First time transplantation.

Procedure: stem cell transplantation

control

NO INTERVENTION

The control group gives injection through intravenous and lumbar puncture ways separately in the corresponding time, but the transplantation matter is physiological saline not the stem cell.

Interventions

stem cell transplantation PROCEDURE

Patients accept a treatment course stem cell transplantation, including one time stem cell transplantation through intravenous injection way at the 10-21th day of cerebral hemorrhage, and the 7-14th day of cerebral infarction incidence; the second time transplantation through lumbar puncture way at the 7th day after the First time transplantation.

Also known as: umbilical cord mesenchyma stem cell transplantation

stem cell transplatation

Eligibility Criteria

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

You may qualify if:

• All tested patients with cerebral infarction, cerebral hemorrhage must tally with the diagnosis standard which in 1995 the Chinese fourth session of brain blood vessel of academic conference formulated, and after the head CT, MRI confirmation. All patients should be taken bad completely within for 24 hours.
• patient's age and gender: 40-65years，the gender is not limit;
• the hemorrhage, block region：One side basis festival area, one side brain stem;
• the patient must catch the apoplexy at the first time and the accidence causes the obvious clinical symptoms.

You may not qualify if:

• Progressive apoplexy;
• other internal organs strict illness sickness, like serious heart disease, diabetes, liver, kidney vigorous sickness and so on;
• the patient with tumor in every system on there body;
• Having the primary or the sequential epilepsy medical history, within one year had the epileptic paroxysm;
• can not accept MRI inspection, for some metal implant in there body(such as inner support in heart or brain blood vessel).

Sponsors & Collaborators

• General Hospital of Chinese Armed Police Forces: lead

Study Sites (1)

Yihua An

Beijing, Beijing Municipality, 100039, China

Location

MeSH Terms

Conditions

Stroke

Interventions

Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• An Yihua, doctor

  Chinese People's Armed Police Force

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2011
• First Posted: July 8, 2011
• Study Start: April 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2012
• Last Updated: February 28, 2013

Record last verified: 2011-10

Locations

CN (1)