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
40
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 Apr 2014
Shorter than P25 for phase_2
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
Study Start
First participant enrolled
April 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 2, 2015
CompletedFirst Posted
Study publicly available on registry
October 7, 2015
CompletedOctober 16, 2015
October 1, 2015
1.3 years
October 2, 2015
October 15, 2015
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 (2)
Change in Muscle tone
3 months and 6 months after transplantation
Number of adverse events
Through study completion, an average of 6 months
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 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.
PMID: 28403842DERIVED
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 2, 2015
First Posted
October 7, 2015
Study Start
April 1, 2014
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
October 16, 2015
Record last verified: 2015-10