Improvement in Gross Motor Function and Muscle Tone in Children With Cerebral Palsy Related to Neonatal Icterus

NCT ID: NCT03123562

Last Updated: 2017-12-26

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-01

Study Completion Date

2016-10-31

Brief Summary

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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

Detailed Description

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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

Conditions

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Cerebral Palsy

Keywords

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Cerebral palsy Stem cells Neonatal icterus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Open Label

Study Groups

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Stem cell transplantation

Stem cell transplantation 2 intrathecal administrations of autologous bone marrow mononuclear cells at baseline and 6 months afterward

Group Type EXPERIMENTAL

Stem cell transplantation

Intervention Type COMBINATION_PRODUCT

Transplantation of Autologous Bone Marrow Mononuclear Cells

Interventions

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Stem cell transplantation

Transplantation of Autologous Bone Marrow Mononuclear Cells

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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Inclusion Criteria

* Cerebral palsy of any types caused by neonatal icterus

Exclusion Criteria

* Epilepsy
* Hydrocephalus with ventricular drain
* Coagulation disorders
* Allergy to anesthetic agents
* Severe health conditions such as cancer, failure of heart, lung, liver or kidney
* Active infections
Minimum Eligible Age

1 Year

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vinmec Research Institute of Stem Cell and Gene Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Vietnam

References

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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.

Reference Type RESULT
PMID: 28403842 (View on PubMed)

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.

Reference Type RESULT
PMID: 905874 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38114596 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31438885 (View on PubMed)

Other Identifiers

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VinmecRISCGT68

Identifier Type: -

Identifier Source: org_study_id