Outcomes of Stem Cells for Cerebral Palsy
Outcomes of Autologous Bone Marrow Mononuclear Cells for Cerebral Palsy: A Self-Controlled Clinical Trial
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 9, 2015
CompletedFirst Posted
Study publicly available on registry
October 14, 2015
CompletedStudy Start
First participant enrolled
November 5, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2018
CompletedMay 7, 2018
May 1, 2018
2.4 years
October 9, 2015
May 1, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Total Score of Gross Motor Function Measure (GMFM)-88
GMFM-88
3 months and 6 months after transplantation
Change in Gross Motor Function Measure (GMFM)-66 Percentile
GMFM-66 percentile
3 months and 6 months after transplantation
Secondary Outcomes (4)
Change in Muscle tone
3 months and 6 months after transplantation
Number of adverse events
Through study completion, an average of 6 months
Change in Denver Developmental Score
3 months and 6 months after transplantation
Change in Quality of Life
3 months and 6 months after transplantation
Study Arms (1)
Stem cell transplantation
EXPERIMENTAL2 intrathecal administrations of autologous bone marrow mononuclear cells at baseline and 3 months afterward
Interventions
Transplantation of Autologous Bone Marrow Mononuclear Cells
Eligibility Criteria
You may qualify if:
- Cerebral palsy of any types caused by oxygen deprivation.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vinmec International Hospital
Hanoi, Vietnam
Related Publications (3)
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.
PMID: 25788947BACKGROUNDThan UTT, Nguyen LT, Nguyen PH, Nguyen XH, Trinh DP, Hoang DH, Nguyen PAT, Dang VD. Inflammatory mediators drive neuroinflammation in autism spectrum disorder and cerebral palsy. Sci Rep. 2023 Dec 18;13(1):22587. doi: 10.1038/s41598-023-49902-8.
PMID: 38114596DERIVEDNguyen TL, Nguyen HP, Nguyen TK. The effects of bone marrow mononuclear cell transplantation on the quality of life of children with cerebral palsy. Health Qual Life Outcomes. 2018 Aug 14;16(1):164. doi: 10.1186/s12955-018-0992-x.
PMID: 30107811DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Liem T Nguyen, MD., PhD.
Vinmec Healthcare System
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2015
First Posted
October 14, 2015
Study Start
November 5, 2015
Primary Completion
March 30, 2018
Study Completion
April 30, 2018
Last Updated
May 7, 2018
Record last verified: 2018-05