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Outcomes of Stem Cells for Cerebral Palsy

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Phase 2
Locations
Vietnam
Study Type
Interventional
Intervention
Autologous Bone Marrow Mononuclear Cells
Sponsored by
Vinmec Healthcare System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Cerebral Palsy, Stem Cells

Eligibility Criteria

1 Year - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Cerebral palsy of any types caused by oxygen deprivation.

Exclusion Criteria:

  • Epilepsy
  • Hydrocephalus with ventricular drain
  • Coagulation disorders
  • Allergy to anesthetic agents
  • Severe health conditions such as cancer, failure of heart, lung, liver or kidney
  • Active infections

Sites / Locations

  • Vinmec International Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stem cell transplantation

Arm Description

2 intrathecal administrations of autologous bone marrow mononuclear cells at baseline and 3 months afterward

Outcomes

Primary Outcome Measures

Change in Total Score of Gross Motor Function Measure (GMFM)-88
GMFM-88
Change in Gross Motor Function Measure (GMFM)-66 Percentile
GMFM-66 percentile

Secondary Outcome Measures

Change in Muscle tone
Muscle tone are assessed by Modified Ashworth Scale
Number of adverse events
Examples of adverse events to look for: anaphylaxis, allergy, respiratory distress, fever, infections, vomit, epilepsy

Full Information

First Posted
October 2, 2015
Last Updated
October 15, 2015
Sponsor
Vinmec Healthcare System
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1. Study Identification

Unique Protocol Identification Number
NCT02569775
Brief Title
Outcomes of Stem Cells for Cerebral Palsy
Official Title
Outcomes of Autologous Bone Marrow Mononuclear Cells for Cerebral Palsy: A Self-Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vinmec Healthcare System

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to assess the safety and effectiveness of autologous bone marrow mononuclear stem cells in patients with cerebral palsy.
Detailed Description
The aim of this study is to assess the safety and effectiveness of autologous bone marrow mononuclear stem cells in 40 patients with cerebral palsy at Vinmec International Hospital, Hanoi, Vietnam.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Cerebral Palsy, Stem Cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stem cell transplantation
Arm Type
Experimental
Arm Description
2 intrathecal administrations of autologous bone marrow mononuclear cells at baseline and 3 months afterward
Intervention Type
Biological
Intervention Name(s)
Autologous Bone Marrow Mononuclear Cells
Intervention Description
Transplantation of Autologous Bone Marrow Mononuclear Cells
Primary Outcome Measure Information:
Title
Change in Total Score of Gross Motor Function Measure (GMFM)-88
Description
GMFM-88
Time Frame
3 months and 6 months after transplantation
Title
Change in Gross Motor Function Measure (GMFM)-66 Percentile
Description
GMFM-66 percentile
Time Frame
3 months and 6 months after transplantation
Secondary Outcome Measure Information:
Title
Change in Muscle tone
Description
Muscle tone are assessed by Modified Ashworth Scale
Time Frame
3 months and 6 months after transplantation
Title
Number of adverse events
Description
Examples of adverse events to look for: anaphylaxis, allergy, respiratory distress, fever, infections, vomit, epilepsy
Time Frame
Through study completion, an average of 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Cerebral palsy of any types caused by oxygen deprivation. Exclusion Criteria: Epilepsy Hydrocephalus with ventricular drain Coagulation disorders Allergy to anesthetic agents Severe health conditions such as cancer, failure of heart, lung, liver or kidney Active infections
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liem T Nguyen, MD., PhD.
Organizational Affiliation
Vinmec Healthcare System
Official's Role
Study Chair
Facility Information:
Facility Name
Vinmec International Hospital
City
Hanoi
Country
Vietnam

12. IPD Sharing Statement

Citations:
PubMed Identifier
25788947
Citation
Sharma A, Sane H, Gokulchandran N, Kulkarni P, Gandhi S, Sundaram J, Paranjape A, Shetty A, Bhagwanani K, Biju H, Badhe P. A clinical study of autologous bone marrow mononuclear cells for cerebral palsy patients: a new frontier. Stem Cells Int. 2015;2015:905874. doi: 10.1155/2015/905874. Epub 2015 Feb 18.
Results Reference
background
PubMed Identifier
28403842
Citation
Nguyen LT, Nguyen AT, Vu CD, Ngo DV, Bui AV. Outcomes of autologous bone marrow mononuclear cells for cerebral palsy: an open label uncontrolled clinical trial. BMC Pediatr. 2017 Apr 12;17(1):104. doi: 10.1186/s12887-017-0859-z.
Results Reference
derived

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Outcomes of Stem Cells for Cerebral Palsy

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