Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this study is to assess the safety and effectiveness of autologous bone marrow mononuclear stem cells in patients with cerebral palsy.
The aim of this study is to assess the safety and effectiveness of autologous bone marrow mononuclear stem cells in 30 patients with cerebral palsy at Vinmec International Hospital, Hanoi, Vietnam.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stem cell transplantation | Experimental | 2 intrathecal administrations of autologous bone marrow mononuclear cells at baseline and 3 months afterward |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Bone Marrow Mononuclear Cells | Biological | Transplantation of Autologous Bone Marrow Mononuclear Cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Muscle tone | Muscle tone are assessed by Modified Ashworth Scale | 3 months and 6 months after transplantation |
| Number of adverse events | Examples of adverse events to look for: anaphylaxis, allergy, respiratory distress, fever, infections, vomit, epilepsy |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Liem T Nguyen, MD., PhD. | Vinmec Healthcare System | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vinmec International Hospital | Hanoi | Vietnam |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25788947 | Background | 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. | |
| 38114596 | Derived |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Through study completion, an average of 6 months |
| Change in Denver Developmental Score | Denver II | 3 months and 6 months after transplantation |
| Change in Quality of Life | Quality of life questionnaire for cerebral palsy (CPQOL) | 3 months and 6 months after transplantation |
| Than 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. |
| 30107811 | Derived | Nguyen 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. |