Outcomes of Stem Cells for Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

Outcomes of Autologous Bone Marrow Mononuclear Cells for Cerebral Palsy: A Self-Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02569775
• Other study ID #: TBG 001
• Status: Completed
• Phase: Phase 2
• First received: October 2, 2015
• Last updated: October 15, 2015
• Start date: April 2014
• Est. completion date: August 2015

Study information

• Verified date: October 2015
• Source: Vinmec International Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Vietnam: Hanoi Department of Health
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to assess the safety and effectiveness of autologous bone marrow mononuclear stem cells in patients with cerebral palsy.

Description:

The aim of this study is to assess the safety and effectiveness of autologous bone marrow mononuclear stem cells in 40 patients with cerebral palsy at Vinmec International Hospital, Hanoi, Vietnam.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 15 Years

Eligibility

Inclusion Criteria:

• Cerebral palsy of any types caused by oxygen deprivation.

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Biological:
• Autologous Bone Marrow Mononuclear Cells
Transplantation of Autologous Bone Marrow Mononuclear Cells

Locations

Country	Name	City	State
Vietnam	Vinmec International Hospital	Hanoi

Sponsors (1)

Lead Sponsor	Collaborator
Vinmec International Hospital

Country where clinical trial is conducted

Vietnam, 

References & Publications (1)

Sharma A, Sane H, Gokulchandran N, Kulkarni P, Gandhi S, Sundaram J, Paranjape A, Shetty A, Bhagwanani K, Biju H, Badhe P. A clinical study of autologous bone marrow mononuclear cells for cerebral palsy patients: a new frontier. Stem Cells Int. 2015;2015:905874. doi: 10.1155/2015/905874. Epub 2015 Feb 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Total Score of Gross Motor Function Measure (GMFM)-88	GMFM-88	3 months and 6 months after transplantation	No
Primary	Change in Gross Motor Function Measure (GMFM)-66 Percentile	GMFM-66 percentile	3 months and 6 months after transplantation	No
Secondary	Change in Muscle tone	Muscle tone are assessed by Modified Ashworth Scale	3 months and 6 months after transplantation	No
Secondary	Number of adverse events	Examples of adverse events to look for: anaphylaxis, allergy, respiratory distress, fever, infections, vomit, epilepsy	Through study completion, an average of 6 months	Yes