Stem Cell Therapy for Cerebral Palsy

NCT ID: NCT01978821

Last Updated: 2018-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2013-08-31

Brief Summary

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the purpose of this study was to study the effect of stem cell therapy on common symptoms of cerebral palsy patients.

Detailed Description

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Conditions

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Cerebral Palsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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stem cell

autologous bone marrow mononuclear cell transplantation

Group Type EXPERIMENTAL

Autologous bone marrow mononuclear cell transplantation

Intervention Type PROCEDURE

Interventions

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Autologous bone marrow mononuclear cell transplantation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Diagnosed cases of any type of Cerebral Palsy
* age above 12 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.
Minimum Eligible Age

17 Months

Maximum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Neurogen Brain and Spine Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Neurogen brain and spine institute

Mumbai, Maharashtra, India

Site Status

Countries

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India

References

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Li Y, Tu L, Chen D, Jiang R, Wang Y, Wang S. [Study on functional recovery of hypoxic-ischemic brain injury by Rg1-induced NSCs]. Zhongguo Zhong Yao Za Zhi. 2012 Feb;37(4):509-14. Chinese.

Reference Type BACKGROUND
PMID: 22667154 (View on PubMed)

Sharma A, Sane H, Paranjape A, Gokulchandran N, Kulkarni P, Nagrajan A, Badhe P. Positron emission tomography-computer tomography scan used as a monitoring tool following cellular therapy in cerebral palsy and mental retardation-a case report. Case Rep Neurol Med. 2013;2013:141983. doi: 10.1155/2013/141983. Epub 2013 Feb 3.

Reference Type BACKGROUND
PMID: 23431488 (View on PubMed)

Wang X, Cheng H, Hua R, Yang J, Dai G, Zhang Z, Wang R, Qin C, An Y. Effects of bone marrow mesenchymal stromal cells on gross motor function measure scores of children with cerebral palsy: a preliminary clinical study. Cytotherapy. 2013 Dec;15(12):1549-62. doi: 10.1016/j.jcyt.2013.06.001. Epub 2013 Oct 5.

Reference Type BACKGROUND
PMID: 24100132 (View on PubMed)

Alvarez P, Carrillo E, Velez C, Hita-Contreras F, Martinez-Amat A, Rodriguez-Serrano F, Boulaiz H, Ortiz R, Melguizo C, Prados J, Aranega A. Regulatory systems in bone marrow for hematopoietic stem/progenitor cells mobilization and homing. Biomed Res Int. 2013;2013:312656. doi: 10.1155/2013/312656. Epub 2013 Jun 17.

Reference Type BACKGROUND
PMID: 23844360 (View on PubMed)

Other Identifiers

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NGBSI-01

Identifier Type: -

Identifier Source: org_study_id

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