Cell Therapy as Treatment for Cerebral Palsy
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ClinicalTrials.gov Identifier: NCT02241395 |
Recruitment Status :
Withdrawn
First Posted : September 16, 2014
Last Update Posted : October 25, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cerebral Palsy | Biological: Intrathecal autologous bone marrow mononuclear cell transplantation | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Autologous Bone Marrow Mononuclear Cell Therapy in Cerebral Palsy |
Study Start Date : | August 2013 |
Estimated Primary Completion Date : | June 2018 |
Estimated Study Completion Date : | December 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: Stem Cell
Intrathecal autologous bone marrow mononuclear cell transplantation
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Biological: Intrathecal autologous bone marrow mononuclear cell transplantation |
- change in clinical symptoms over a period of 2 years [ Time Frame: 2 years ]Clinical symptoms such as oromotor skills, sitting and standing balance, speech, ambulation, muscle tone, cognition, hand and leg movement, walking, etc
- Change in GMFM score [ Time Frame: 1 year ]
- Change in Gross Motor Function Measure [ Time Frame: 1 year ]

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Ages Eligible for Study: | 6 Months to 35 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02241395
India | |
Neurogen brain and spine institute | |
Navi Mumbai, Maharashtra, India, 400706 |
Responsible Party: | Neurogen Brain and Spine Institute |
ClinicalTrials.gov Identifier: | NCT02241395 |
Other Study ID Numbers: |
NGBSI-09 |
First Posted: | September 16, 2014 Key Record Dates |
Last Update Posted: | October 25, 2018 |
Last Verified: | October 2018 |
Cerebral Palsy autologous bone marrow mononuclear cells stem cell |
Paralysis Cerebral Palsy Neurologic Manifestations Nervous System Diseases |
Brain Damage, Chronic Brain Diseases Central Nervous System Diseases |