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

Cerebral Palsy Clinical Trial

Official title:

Improvement in Gross Motor Function and Muscle Tone in Children With Cerebral Palsy Related to Neonatal Icterus: An Open-label, Uncontrolled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03123562
• Other study ID #: VinmecRISCGT68
• Status: Completed
• Phase: Phase 2
• First received: April 17, 2017
• Last updated: December 22, 2017
• Start date: April 1, 2014
• Est. completion date: October 31, 2016

Study information

• Verified date: December 2017
• Source: Vinmec Research Institute of Stem Cell and Gene Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and effectiveness of stem cells for cerebral palsy related to neonatal icterus

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: October 31, 2016
• Est. primary completion date: September 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Jaundice
• Paralysis

Intervention

Combination Product:
• Stem cell transplantation
Transplantation of Autologous Bone Marrow Mononuclear Cells

Locations

Country	Name	City	State
Vietnam	Vinmec Research Institute of Stem Cell and Gene Technology	Hanoi

Sponsors (1)

Lead Sponsor	Collaborator
Vinmec Research Institute of Stem Cell and Gene Technology

Country where clinical trial is conducted

Vietnam, 

References & Publications (2)

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. Serbian. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Change in Muscle tone	Muscle tone are assessed by Modified Ashworth Scale	Time Frame: Baseline and 6 months after transplantation
Secondary	Number of adverse events	Examples of adverse events to look for: fever, infections, vomit, epilepsy	Through study completion, an average of 6 months