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Status unknownNCT01908400Updated Sep 17, 2014

Safety and Efficacy of BMMNCin Patients With Mental Retardation

A Phase 1/2 interventional study of Intravenous transfer of BMMNC in Mental Retardation, sponsored by Chaitanya Hospital, Pune. Status unknown at 1 site in India. Open to participants aged 5 Years to 50 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has not verified this record recently (last verified Sep 2014), so the status shown — last known as Recruiting — may be out of date.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
15
Allocation
Not applicable
Ages
5 Years to 50 Years
Sex
All
01

Study summary

Mental retardation is a condition diagnosed before age 18 that includes below-average general intellectual function, and a lack of the skills necessary for daily living. Mental retardation affects about 1 - 3% of the population. There are many causes of mental retardation, but find a specific reason in only 25% of cases.Bone marrow derived stem cells are used in this condition to prove its safety and efficacy .

02

Conditions studied

  • Mental Retardation

Keywords

  • Mental retardation , stem cell,BMMNC
03

In context

Intellectual Disability

363 studies on the registry are indexed under Intellectual Disability; 103 are open to participants now.

This study's planned enrollment of 15 is below the median of 53 across 236 interventional studies indexed under Intellectual Disability.

Browse Intellectual Disability 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.

04

Who can participate

Ages eligible
5 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age limit: 5 -50
  • Primary diagnosis of mental retardation (IQ \< 70)
  • willingness to undergo Autologous Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs) transplantation.
  • To give an informed consent as well as sign the required Informed Consent Form (ICF)/video Consent for the study.
  • willingness to regularly visit the hospital / clinic for follow up during the follow up period / on prior agreed time points as per the protocol.

Exclusion criteria

Exclusion Criteria:

  • Positive test results for HIV and AIDS complex ,HCV (hepatitis C virus ), HbsAg and Syphilis
  • Advanced age that may produce deteriorating cognitive or motor functioning
  • Multiple sensory or motor disabilities that will interfere with seeing the stimuli and responding to the computer
  • Poor general health
05

Study design

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

Study arms

  • Other
    BMMNCs

    Intravenous transfer of (BMMNCs)

    Biological: Intravenous transfer of BMMNC

Interventions

  • BiologicalIntravenous transfer of BMMNC

    Intervention therapy , Total 3 doses ,in 30 days ,in 7days interval Intravenous transfer of Autologous Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs)

06

What researchers measure

Primary outcomes

  1. Binet-Kamat Test

    CHANGE in IQ as measured by Binet-Kamat Test

    Time frame: 1 YEAR

Secondary outcomes

  1. Vineland Social Maturity Scale

    CHANGE in Social Quotient as measured by Vineland Social Maturity Scale

    Time frame: baseline and 12 months

07

Study locations

1 of 1 sites recruiting
  • Chaitanya Hospital
    Pune,, Maharashtra 411030, India
    • Sachin P Jamadar, D ORTHO · Contact · sac2751982@gmail.com · +918888788880
    • Anant E Bagul, MS,Ortho · Principal investigator
    Recruiting
08

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 ↗
09

Registry details

Key details

Study ID
NCT01908400
Lead sponsor
Chaitanya Hospital, Pune
Responsible party
Dr. Sachin Jamadar (Co -investigator, Chaitanya Hospital, Pune) — Principal investigator
First posted
Jul 25, 2013
Start date
Sep 2014
Primary completion
Nov 2016 (estimated)
Completion
Nov 2016 (estimated)
Last update
Sep 17, 2014

Study contacts

Sachin P Jamadar, D.Ortho
Contact
sac2751982@gmail.com
918888788880
ANANT E BAGUL, MS ORTHO
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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Discussion

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