NCT01834664

Brief Summary

This Study is Single arm, Single Centre trial to study the safety and efficacy of bone marrow derived autologous mononuclear cells (100 millions per dose)study enrollment duration 36 months sample size 100 patients should be treated (above 15 years of age) with cerebral palsy in India. Primary outcome measures are improvement in walking ability and kinetic gait pattern.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2013

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 8, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 18, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

September 17, 2014

Status Verified

September 1, 2014

Enrollment Period

3.3 years

First QC Date

April 8, 2013

Last Update Submit

September 16, 2014

Conditions

Ataxic Infantile Cerebral Palsy

Keywords

Ataxic Infantile Cerebral Palsy stem cell therapy

Outcome Measures

Primary Outcomes (1)

  • Improvement in muscle rigidity using Ash worth scale

    6 Months

Secondary Outcomes (5)

  • Improvement in dysregulated phospholipid Metabolism

    6 months

  • Improvement in walking ability and kinetic gait Pattern

    6 Months

  • Improvement in overall motor control using oxford scale

    6 Months

  • Improvement in orbitoFrontal-amygdala circuit and self-regulation of social -emotional behaviour

    6 month

  • Improvement in motor-linked implicit learning

    6 month

Study Arms (1)

STEM CELL

OTHER

Transfer of autologous stem cell \[MNCs \]intrathecally

Biological: stem cell (MNCs )

Interventions

stem cell (MNCs )BIOLOGICAL

Intra thecal transplantation of autologous stem cell \[MNCs \]Per dose at the interval

Also known as: Intra thecal autologous stem cell MNCs
STEM CELL

Eligibility Criteria

Age15 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subject aged above 15 years with a diagnosis of Cerebral Palsy. Regional Nerve damage as shown by Magnetic Resonance Imaging(MRI)
  • Patient suffer from cerebral palsy due to prenatal and postnatal cause,
  • Willing to undergoing Bone Marrow derived autologous stem cell therapy.
  • Able to Comprehend and give written informed consent form for the study
  • willing to come to the hospital for follow up visits as per the protocol requirements

You may not qualify if:

  • History of meningitis,meningoencephalitis , epilepsy or life threatening allergic or immune -mediated reaction
  • Hemodynamically unstable patients
  • history of or concurrent autoimmune disease or acute episode if Guillain- barre syndrome
  • peripheral Muscular dystrophy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chaitanya Hospital

Pune, Maharashtra, 411009, India

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy, Ataxic, Autosomal Recessive

Study Officials

  • ANANT E BAGUL, M.S

    CHAITANYA HOSPITAL

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sachin S Jamadar, Dortho

CONTACT

+918888788880sac2751982@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
CO-Investigator

Study Record Dates

First Submitted

April 8, 2013

First Posted

April 18, 2013

Study Start

March 1, 2013

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

September 17, 2014

Record last verified: 2014-09

Locations

IN(1)