NCT01978821

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2010

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 8, 2013

Completed
Last Updated

October 25, 2018

Status Verified

October 1, 2018

Enrollment Period

3 years

First QC Date

October 25, 2013

Last Update Submit

October 23, 2018

Conditions

Keywords

Cerebral Palsyautologous bone marrow mononuclear cellsstem cell therapy

Outcome Measures

Primary Outcomes (1)

  • Change in clinical symptoms of cerebral palsy after 6 months

    Six months

Study Arms (1)

stem cell

EXPERIMENTAL

autologous bone marrow mononuclear cell transplantation

Procedure: Autologous bone marrow mononuclear cell transplantation

Interventions

Eligibility Criteria

Age17 Months - 22 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neurogen brain and spine institute

Mumbai, Maharashtra, 400071, India

Location

Related Publications (4)

  • 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.

    PMID: 22667154BACKGROUND
  • 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.

    PMID: 23431488BACKGROUND
  • 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.

    PMID: 24100132BACKGROUND
  • 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.

    PMID: 23844360BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2013

First Posted

November 8, 2013

Study Start

August 1, 2010

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

October 25, 2018

Record last verified: 2018-10

Locations