Cerebral Palsy Clinical Trial
Official title:
Outcomes of Autologous Bone Marrow Mononuclear Cells for Cerebral Palsy: A Self-Controlled Clinical Trial
Verified date | May 2018 |
Source | Vinmec Healthcare System |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to assess the safety and effectiveness of autologous bone marrow mononuclear stem cells in patients with cerebral palsy.
Status | Completed |
Enrollment | 30 |
Est. completion date | April 30, 2018 |
Est. primary completion date | March 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 15 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Vietnam | Vinmec International Hospital | Hanoi |
Lead Sponsor | Collaborator |
---|---|
Vinmec Healthcare System |
Vietnam,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Total Score of Gross Motor Function Measure (GMFM)-88 | GMFM-88 | 3 months and 6 months after transplantation | |
Primary | Change in Gross Motor Function Measure (GMFM)-66 Percentile | GMFM-66 percentile | 3 months and 6 months after transplantation | |
Secondary | Change in Muscle tone | Muscle tone are assessed by Modified Ashworth Scale | 3 months and 6 months after transplantation | |
Secondary | Number of adverse events | Examples of adverse events to look for: anaphylaxis, allergy, respiratory distress, fever, infections, vomit, epilepsy | Through study completion, an average of 6 months | |
Secondary | Change in Denver Developmental Score | Denver II | 3 months and 6 months after transplantation | |
Secondary | Change in Quality of Life | Quality of life questionnaire for cerebral palsy (CPQOL) | 3 months and 6 months after transplantation |
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