NCT02241395

Brief Summary

The purpose of this study was to study the effect of autologous bone marrow mononuclear cells 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 2013

Longer than P75 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withdrawn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, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2014

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

October 25, 2018

Status Verified

October 1, 2018

Enrollment Period

4.8 years

First QC Date

September 12, 2014

Last Update Submit

October 23, 2018

Conditions

Cerebral Palsy

Keywords

Cerebral Palsyautologous bone marrow mononuclear cellsstem cell

Outcome Measures

Primary Outcomes (1)

  • change in clinical symptoms over a period of 2 years

    Clinical symptoms such as oromotor skills, sitting and standing balance, speech, ambulation, muscle tone, cognition, hand and leg movement, walking, etc

    2 years

Secondary Outcomes (2)

  • Change in GMFM score

    1 year

  • Change in Gross Motor Function Measure

    1 year

Study Arms (1)

Stem Cell

EXPERIMENTAL

Intrathecal autologous bone marrow mononuclear cell transplantation

Biological: Intrathecal autologous bone marrow mononuclear cell transplantation

Interventions

Intrathecal autologous bone marrow mononuclear cell transplantationBIOLOGICAL
Stem Cell

Eligibility Criteria

Age6 Months - 35 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 6 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

Navi Mumbai, Maharashtra, 400706, India

Location

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

September 12, 2014

First Posted

September 16, 2014

Study Start

August 1, 2013

Primary Completion

June 1, 2018

Study Completion

December 1, 2018

Last Updated

October 25, 2018

Record last verified: 2018-10

Locations

IN(1)