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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 40 patients with cerebral palsy at Vinmec International Hospital, Hanoi, Vietnam.
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Through study completion, an average of 6 months |
| 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. |
| 28403842 | Derived | 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. |