Cell Therapy as Treatment for Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

Autologous Bone Marrow Mononuclear Cell Therapy in Cerebral Palsy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02241395
• Other study ID #: NGBSI-09
• Status: Withdrawn
• Phase: Phase 1
• Start date: August 2013
• Est. completion date: December 2018

Study information

• Verified date: October 2018
• Source: Neurogen Brain and Spine Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to study the effect of autologous bone marrow mononuclear cells on common symptoms of cerebral palsy patients.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 35 Years

Eligibility

Inclusion Criteria:

• diagnosed cases of any type of Cerebral Palsy

• age above 6 months.

Exclusion Criteria:

• presence of acute infections such as Human immunodeficiency virus/Hepatitis B Virus/ Hepatitis C Virus

• malignancies

• bleeding tendencies

• pneumonia

• renal failure

• severe liver dysfunction

• severe anemia [Hemoglobin < 8]

• any bone marrow disorder

• space occupying lesion in brain

• other acute medical conditions such as respiratory infection and pyrexia.

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis

Intervention

Biological:
• Intrathecal autologous bone marrow mononuclear cell transplantation

Locations

Country	Name	City	State
India	Neurogen brain and spine institute	Navi Mumbai	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Neurogen Brain and Spine Institute

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in clinical symptoms over a period of 2 years	Clinical symptoms such as oromotor skills, sitting and standing balance, speech, ambulation, muscle tone, cognition, hand and leg movement, walking, etc	2 years
Secondary	Change in GMFM score		1 year
Secondary	Change in Gross Motor Function Measure		1 year