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WithdrawnNCT01978821Updated Oct 25, 2018

Stem Cell Therapy for Cerebral Palsy

A Phase 1 interventional study of Autologous bone marrow mononuclear cell transplantation in Cerebral Palsy, sponsored by Neurogen Brain and Spine Institute. Withdrawn at 1 site in India. Open to participants aged 17 Months to 22 Years. Per ClinicalTrials.gov, last updated 2018-10-25.

Sponsored by Neurogen Brain and Spine Institute · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
17 Months to 22 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Cerebral Palsy

Keywords

  • Cerebral Palsy
  • autologous bone marrow mononuclear cells
  • stem cell therapy
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In context

Paralysis

750 studies on the registry are indexed under Paralysis; 133 are open to participants now.

Browse Paralysis studies →

Lead sponsor

Neurogen Brain and Spine Institute is the lead sponsor of 16 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
17 Months to 22 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosed cases of any type of Cerebral Palsy
  • age above 12 months.

Exclusion criteria

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.
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    stem cell

    autologous bone marrow mononuclear cell transplantation

    Procedure: Autologous bone marrow mononuclear cell transplantation

Interventions

  • ProcedureAutologous bone marrow mononuclear cell transplantation
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What researchers measure

Primary outcomes

  1. Change in clinical symptoms of cerebral palsy after 6 months

    Time frame: Six months

07

Study locations

1 site
  • Neurogen brain and spine institute
    Mumbai, Maharashtra 400071, India
08

References and documents

Publications

  • 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. PubMed 22667154 ↗
  • 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. PubMed 23431488 ↗
  • 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. PubMed 24100132 ↗
  • 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. PubMed 23844360 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 25, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01978821
Lead sponsor
Neurogen Brain and Spine Institute
Responsible party
Sponsor
First posted
Nov 8, 2013
Start date
Aug 2010
Primary completion
Aug 2013
Completion
Aug 2013
Last update
Oct 25, 2018

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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