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Cell Therapy as Treatment for Cerebral Palsy

Primary Purpose

Cerebral Palsy

Status

Withdrawn

Phase

Phase 1

Locations

India

Study Type

Interventional

Intervention

Intrathecal autologous bone marrow mononuclear cell transplantation

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Cerebral Palsy, autologous bone marrow mononuclear cells, stem cell

Eligibility Criteria

6 Months - 35 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Neurogen brain and spine institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stem Cell

Arm Description

Intrathecal autologous bone marrow mononuclear cell transplantation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in GMFM score

Change in Gross Motor Function Measure

Full Information

NCT ID

NCT02241395

First Posted

September 12, 2014

Last Updated

October 23, 2018

Sponsor

Neurogen Brain and Spine Institute

1. Study Identification

Unique Protocol Identification Number

NCT02241395

Brief Title

Cell Therapy as Treatment for Cerebral Palsy

Official Title

Autologous Bone Marrow Mononuclear Cell Therapy in Cerebral Palsy

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Withdrawn

Study Start Date

August 2013 (undefined)

Primary Completion Date

June 2018 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Neurogen Brain and Spine Institute

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cerebral Palsy

Keywords

Cerebral Palsy, autologous bone marrow mononuclear cells, stem cell

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Stem Cell

Arm Type

Experimental

Arm Description

Intrathecal autologous bone marrow mononuclear cell transplantation

Intervention Type

Biological

Intervention Name(s)

Intrathecal autologous bone marrow mononuclear cell transplantation

Primary Outcome Measure Information:

Title

change in clinical symptoms over a period of 2 years

Description

Clinical symptoms such as oromotor skills, sitting and standing balance, speech, ambulation, muscle tone, cognition, hand and leg movement, walking, etc

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Change in GMFM score

Time Frame

1 year

Title

Change in Gross Motor Function Measure

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

Facility Name

Neurogen brain and spine institute

City

Navi Mumbai

State/Province

Maharashtra

ZIP/Postal Code

400706

Country

India

12. IPD Sharing Statement

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Cell Therapy as Treatment for Cerebral Palsy

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