Outcomes of Autologous Bone Marrow Mononuclear Cell Administration in the Treatment of Neurologic Sequelea in Children With Spina Bifida
NCT ID: NCT05472428
Last Updated: 2022-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
11 participants
INTERVENTIONAL
2016-07-01
2021-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Autologous BMMNC transplantation
\- Autologous bone marrow mononuclear cell transplantation 2 intrathecal administrations of autologous bone marrow mononuclear cells at baseline and 6 months afterward
Autologous bone marrow mononuclear cell transplantation
Transplantation of Autologous Bone Marrow Mononuclear cells
Interventions
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Autologous bone marrow mononuclear cell transplantation
Transplantation of Autologous Bone Marrow Mononuclear cells
Eligibility Criteria
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Inclusion Criteria
* Both genders.
* Aged between 6 months and 15 years old.
* Exhibited bowel disorders (constipation, fecal incontinence) and urinary dysfunction (urinary retention or leakage).
Exclusion Criteria
* Coagulopathy.
* Acute and chronic infection.
* Kidney function disorder, liver failure
* Patients with complex cardiovascular diseases (including valvular heart disease, cardiomyopathy, arrhythmia, congenital heart disease, hypertrophy syndrome).
* Distress
6 Months
15 Years
ALL
No
Sponsors
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Vinmec Health Care System (Vingroup Joint Stock Company)
UNKNOWN
Vinmec Research Institute of Stem Cell and Gene Technology
OTHER
Responsible Party
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Principal Investigators
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Liem T Nguyen, MD., PhD
Role: PRINCIPAL_INVESTIGATOR
Vinmec Research Institute of Stem Cell and Gene Technology
Locations
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Vinmec Research Institute of Stem Cell and Gene Technology
Hanoi, , Vietnam
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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CS. ĐT.19H1
Identifier Type: -
Identifier Source: org_study_id
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