Cell Therapy as Treatment for Cerebral Palsy

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02241395
• Date of registration: 12/09/2014
• Prospective Registration: No
• Primary sponsor: Neurogen Brain and Spine Institute
• Public title: Cell Therapy as Treatment for Cerebral Palsy
• Scientific title: Autologous Bone Marrow Mononuclear Cell Therapy in Cerebral Palsy
• Date of first enrolment: August 2013
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT02241395
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

India

Key inclusion & exclusion criteria

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.



Age minimum: 6 Months
Age maximum: 35 Years
Gender: All

Health Condition(s) or Problem(s) studied

Cerebral Palsy

Intervention(s)

Biological: Intrathecal autologous bone marrow mononuclear cell transplantation

Primary Outcome(s)

change in clinical symptoms over a period of 2 years [Time Frame: 2 years]

Secondary Outcome(s)

Change in GMFM score [Time Frame: 1 year]

Change in Gross Motor Function Measure [Time Frame: 1 year]

Secondary ID(s)

NGBSI-09

Source(s) of Monetary Support

Please refer to primary and secondary sponsors