search
Back to results

A Clinical Trial to Study the Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Autism (BMCA)

Primary Purpose

Autism

Status
Unknown status
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
STEM CELL THERAPY
Sponsored by
Chaitanya Hospital, Pune
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism focused on measuring Autism stem cell MNCs

Eligibility Criteria

3 Years - 70 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Chaitanya HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

STEM CELL

Arm Description

intra thecal injection of MNC stem cell therapy

Outcomes

Primary Outcome Measures

Improvement in childhood autism rating scale

Secondary Outcome Measures

Improvement in perfusion of brain with PET scan report

Full Information

First Posted
February 26, 2013
Last Updated
September 16, 2014
Sponsor
Chaitanya Hospital, Pune
search

1. Study Identification

Unique Protocol Identification Number
NCT01836562
Brief Title
A Clinical Trial to Study the Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Autism
Acronym
BMCA
Official Title
A Clinical Trial to Study the Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Autism. It is Self Funded (Patients' Own Funding) Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
June 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chaitanya Hospital, Pune

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Autism is a developmental disorder that appears in the first 3 years of life, and affects the brain's normal development of social and communication skills. Autism is a physical condition linked to abnormal biology and chemistry in the brain. The exact causes of these abnormalities remain unknown,Symptoms-Children with autism typically have difficulties in: Pretend play, Social interactions, Verbal and non-verbal communication. Some children with autism appear normal before age 1 or 2 and then suddenly "regress" and lose language or social skills they had previously gained. This is called the regressive type of autism. People with autism may: Be overly sensitive in sight, hearing, touch, smell, or taste.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism
Keywords
Autism stem cell MNCs

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
STEM CELL
Arm Type
Other
Arm Description
intra thecal injection of MNC stem cell therapy
Intervention Type
Biological
Intervention Name(s)
STEM CELL THERAPY
Other Intervention Name(s)
Intra thecal injection of autologous MNC
Intervention Description
Intra thecal injection of autologous MNC ,Intra thecal inj.of 100 millions MNC in 3 doses at 10 days interval.
Primary Outcome Measure Information:
Title
Improvement in childhood autism rating scale
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Improvement in perfusion of brain with PET scan report
Time Frame
6 MONTH

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sachin P Jamadar, D.Ortho
Phone
+918888788880
Email
sac2751982@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Smita S Bhoyar, B.A.M.S.PGCR
Phone
9372620569
Email
drsmitabhoyar@rediff.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ANANT E BAGUL, M.S
Organizational Affiliation
CHAITANYA HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chaitanya Hospital
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411009
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sachin P Jamadar, D ORTHO
Phone
+918888788880
Email
sac2751982@gmail.com
First Name & Middle Initial & Last Name & Degree
Smita S Bhoyar, BAMS.PGCR
Phone
9372620569
Email
drsmitabhoyar@rediffmail.com
First Name & Middle Initial & Last Name & Degree
Dr, Anant E Bagul, MS

12. IPD Sharing Statement

Learn more about this trial

A Clinical Trial to Study the Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Autism

We'll reach out to this number within 24 hrs