NCT01836562

Brief Summary

This clinical trial is a single Arm, single centre to check the safety and efficacy of bone marrow derived autologous mono nuclear cells (MNC) (100 million per dose). Trial to be conducted for 36 months.

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 Sep 2014

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 22, 2013

Completed
1.4 years until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
1.8 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

1.8 years

First QC Date

February 26, 2013

Last Update Submit

September 16, 2014

Conditions

Autism

Keywords

Autism stem cell MNCs

Outcome Measures

Primary Outcomes (1)

  • Improvement in childhood autism rating scale

    6 month

Secondary Outcomes (1)

  • Improvement in perfusion of brain with PET scan report

    6 MONTH

Study Arms (1)

STEM CELL

OTHER

intra thecal injection of MNC stem cell therapy

Biological: STEM CELL THERAPY

Interventions

STEM CELL THERAPYBIOLOGICAL

Intra thecal injection of autologous MNC ,Intra thecal inj.of 100 millions MNC in 3 doses at 10 days interval.

Also known as: Intra thecal injection of autologous MNC
STEM CELL

Eligibility Criteria

Age3 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patient should suffer from Autism.
  • willingness to undergo bone marrow derived autologous cell therapy.
  • patient those provide fully Informed consent form for the study.
  • Ability and willingness to regular visit to hospital and follow up during the protocol Procedures.

You may not qualify if:

  • Patients with pre - existing or Current systemic disease such as lung , liver ( exception; History of uncomplicated Hepatitis A),gastrointestinal, Cardiac , Immunodeficiency,(including HIV) Or laboratory Investigation that could cause a neurological defect.History of Life threatening Allergic or immune- mediated reaction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chaitanya Hospital

Pune, Maharashtra, 411009, India

RECRUITING

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • ANANT E BAGUL, M.S

    CHAITANYA HOSPITAL

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sachin P Jamadar, D.Ortho

CONTACT

+918888788880sac2751982@gmail.com

Smita S Bhoyar, B.A.M.S.PGCR

CONTACT

9372620569drsmitabhoyar@rediff.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

February 26, 2013

First Posted

April 22, 2013

Study Start

September 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

September 17, 2014

Record last verified: 2014-09

Locations

IN(1)