CClinicalTrials.gg
Status unknownNCT01836562BMCAUpdated Sep 17, 2014

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

A Phase 1/2 interventional study of STEM CELL THERAPY in Autism, sponsored by Chaitanya Hospital, Pune. Status unknown at 1 site in India. Open to participants aged 3 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-09-17.

Sponsored by Chaitanya Hospital, Pune · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2014), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
3 Years to 70 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Autism

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Keywords

  • Autism stem cell MNCs
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In context

Autistic Disorder

1,344 studies on the registry are indexed under Autistic Disorder; 334 are open to participants now.

This study's planned enrollment of 100 is above the median of 45 across 1,044 interventional studies indexed under Autistic Disorder.

Browse Autistic Disorder studies →

Lead sponsor

Chaitanya Hospital, Pune is the lead sponsor of 14 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
3 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Other
    STEM CELL

    intra thecal injection of MNC stem cell therapy

    Biological: STEM CELL THERAPY

Interventions

  • BiologicalSTEM CELL THERAPY

    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

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What researchers measure

Primary outcomes

  1. Improvement in childhood autism rating scale

    Time frame: 6 month

Secondary outcomes

  1. Improvement in perfusion of brain with PET scan report

    Time frame: 6 MONTH

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Study locations

1 of 1 sites recruiting
  • Chaitanya Hospital
    Pune, Maharashtra 411009, India
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01836562
Lead sponsor
Chaitanya Hospital, Pune
Responsible party
Dr. Sachin Jamadar (CO-Investigator, Chaitanya Hospital, Pune) — Principal investigator
First posted
Apr 22, 2013
Start date
Sep 2014
Primary completion
Jun 2016 (estimated)
Completion
Jun 2016 (estimated)
Last update
Sep 17, 2014

Study contacts

Sachin P Jamadar, D.Ortho
Contact
sac2751982@gmail.com
+918888788880
Smita S Bhoyar, B.A.M.S.PGCR
Contact
drsmitabhoyar@rediff.com
9372620569
ANANT E BAGUL, M.S
principal investigator · CHAITANYA HOSPITAL

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

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