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The purpose of this study is to evaluate the safety and effectiveness of stem cells for cerebral palsy related to neonatal icterus
The purpose of this study is to evaluate the safety and effectiveness of autologous bone marrow mononuclear stem cells in 25 patients with cerebral palsy related to neonatal icterus at Vinmec International Hospital, Hanoi, Vietnam
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stem cell transplantation | Experimental | Stem cell transplantation 2 intrathecal administrations of autologous bone marrow mononuclear cells at baseline and 6 months afterward |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stem cell transplantation | Combination Product | Transplantation of Autologous Bone Marrow Mononuclear Cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| GMFM-88 and GMFM-66 Percentile | Change in Total Score of Gross Motor Function Measure GMFM-88 and GMFM-66 Percentile | Time Frame: Baseline and 6 months after transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Muscle tone | Muscle tone are assessed by Modified Ashworth Scale | Time Frame: Baseline and 6 months after transplantation |
| Number of adverse events | Examples of adverse events to look for: 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 Research Institute of Stem Cell and Gene Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vinmec Research Institute of Stem Cell and Gene Technology | Hanoi | 100000 | Vietnam |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28403842 | Result | 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. | |
| 905874 | Result | Jasovic M, Kamenica S, Draganic M, Vasovic P, Nikolajevic A. [Differential diagnosis between mediastinal tumors and aneurysms of the thoracic aorta]. Srp Arh Celok Lek. 1977 Jan;105(1):39-45. No abstract available. Serbian. |
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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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| ID | Term |
|---|---|
| D033581 | Stem Cell Transplantation |
| ID | Term |
|---|---|
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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Open Label
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| Through study completion, an average of 6 months |
| 38114596 | Derived | 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. |
| 31438885 | Derived | Thanh LN, Trung KN, Duy CV, Van DN, Hoang PN, Phuong ANT, Ngo MD, Thi TN, Viet AB. Improvement in gross motor function and muscle tone in children with cerebral palsy related to neonatal icterus: an open-label, uncontrolled clinical trial. BMC Pediatr. 2019 Aug 22;19(1):290. doi: 10.1186/s12887-019-1669-2. |
| D014180 |
| Transplantation |
| D013514 | Surgical Procedures, Operative |