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| Name | Class |
|---|---|
| Vinmec Health Care System (Vingroup Joint Stock Company) | UNKNOWN |
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The aim of this study was to evaluate the safety and efficacy of autologous bone marrow mononuclear cell infusion in the management of neurological sequelae in children with spina bifida
The aim of this study was to evaluate the safety and effectiveness of autologous bone marrow mononuclear cells in 11 patients with spina bifida at Vinmec Research Institute of Stem Cell and Gene Technology in Hanoi, Vietnam from 2016 to 2020
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous BMMNC transplantation | Experimental | - Autologous bone marrow mononuclear 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 |
|---|---|---|---|---|
| Autologous bone marrow mononuclear cell transplantation | Combination Product | Transplantation of Autologous Bone Marrow Mononuclear cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events and serious adverse events | Incidence of the adverse events or serious adverse events after infusion | up to the 12-month period following treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Bristol stool scale | The Bristol stool scale comes in 7 types: Type 1-2 indicate constipation; type 3-4 are ideal stools as they are easier to pass; type 5-7 may show diarrhea and urgency. | up to the 12-month period following treatment |
| Rectoanal inhibitory reflex |
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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 |
|---|---|---|---|
| 30143601 | Result | Liem NT, Chinh VD, Thinh NT, Minh ND, Duc HM. Improved Bowel Function in Patients with Spina Bifida After Bone Marrow-Derived Mononuclear Cell Transplantation: A Report of 2 Cases. Am J Case Rep. 2018 Aug 25;19:1010-1018. doi: 10.12659/AJCR.909801. | |
| 25678991 | Result | Aghayan HR, Arjmand B, Yaghoubi M, Moradi-Lakeh M, Kashani H, Shokraneh F. Clinical outcome of autologous mononuclear cells transplantation for spinal cord injury: a systematic review and meta-analysis. Med J Islam Repub Iran. 2014 Oct 14;28:112. eCollection 2014. |
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Open Label
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The rectoanal inhibitory reflex (RAIR) is a reflex characterized by transient involuntary relaxation of the internal anal sphincter in response to distention of the rectum with the normal value <= 14.7 ml |
| up to the 12-month period following treatment |
| Bladder sensation | The cystometry was used to assess bladder sensation | up to the 12-month period following treatment |
| Urinary retention | urinary retention is assessed via cytometry | up to the 12-month period following treatment |
| Urinary incontinence | Urinary incontinence is assessed via cytometry | up to the 12-month period following treatment |
| Lower limb motor functions | Lower limb motor function was assessed via manual muscle testing (MMT) | up to the 12-month period following treatment |
| 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. |
| 37118832 | Derived | Nguyen LT, Le HT, Nguyen KT, Bui HT, Nguyen APT, Ngo DV, Hoang DM, Ngo MD. Outcomes of autologous bone marrow mononuclear cell administration in the treatment of neurologic sequelae in children with spina bifida. Stem Cell Res Ther. 2023 Apr 28;14(1):115. doi: 10.1186/s13287-023-03349-w. |
| ID | Term |
|---|---|
| D016135 | Spinal Dysraphism |
| ID | Term |
|---|---|
| D009436 | Neural Tube Defects |
| D009421 | Nervous System Malformations |
| D009422 | Nervous System Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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