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Stem Cell Therapy for Cerebral Palsy

Primary Purpose

Cerebral Palsy

Status
Withdrawn
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
Autologous bone marrow mononuclear cell transplantation
Sponsored by
Neurogen Brain and Spine Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

17 Months - 22 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Neurogen brain and spine institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

stem cell

Arm Description

autologous bone marrow mononuclear cell transplantation

Outcomes

Primary Outcome Measures

Change in clinical symptoms of cerebral palsy after 6 months

Secondary Outcome Measures

Full Information

First Posted
October 25, 2013
Last Updated
October 23, 2018
Sponsor
Neurogen Brain and Spine Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01978821
Brief Title
Stem Cell Therapy for Cerebral Palsy
Official Title
Open Label Study of Autologous Bone Marrow Mononuclear Cells in Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Withdrawn
Study Start Date
August 2010 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

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 stem cell therapy 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 therapy

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
autologous bone marrow mononuclear cell transplantation
Intervention Type
Procedure
Intervention Name(s)
Autologous bone marrow mononuclear cell transplantation
Primary Outcome Measure Information:
Title
Change in clinical symptoms of cerebral palsy after 6 months
Time Frame
Six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Months
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Neurogen brain and spine institute
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400071
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
22667154
Citation
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.
Results Reference
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PubMed Identifier
23431488
Citation
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.
Results Reference
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PubMed Identifier
24100132
Citation
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.
Results Reference
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PubMed Identifier
23844360
Citation
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.
Results Reference
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Stem Cell Therapy for Cerebral Palsy

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