NCT02245724

Brief Summary

The purpose of this study was to analyze the benefit of autologous mononuclear cell therapy in mental retardation.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2011

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Study Start

First participant enrolled

September 1, 2011

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 22, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

October 25, 2018

Status Verified

October 1, 2018

Enrollment Period

4.5 years

First QC Date

September 12, 2014

Last Update Submit

October 23, 2018

Conditions

Mental Retardation

Keywords

Mental retardationAutologous mononuclear cell therapyStem cell

Outcome Measures

Primary Outcomes (1)

  • Change in common clinical symptoms of mental retardation

    Change in symptoms such as cognition, remote memory, problem solving,understanding of relationships,social interaction,communication,self care, activities of daily living will be recorded at 1 year follow up.

    1 year

Study Arms (1)

Stem Cell

EXPERIMENTAL

Bone marrow mononuclear cell transplantation

Biological: Stem Cell

Interventions

Stem CellBIOLOGICAL

Autologous bone marrow mononuclear cell transplantation

Stem Cell

Eligibility Criteria

Age6 Months - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • diagnosed cases of mental retardation
  • age above 6 months

You may not qualify if:

  • presence of acute infections such as Human immunodeficiency virus/Hepatitis B Virus/Hepatitis C Virus
  • malignancies
  • bleeding tendencies
  • pneumonia
  • renal failure
  • severe liver dysfunction
  • severe anemia \[Hemoglobin \< 8\]
  • any bone marrow disorder
  • space occupying lesion in brain
  • other acute medical conditions such as respiratory infection and pyrexia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neurogen brain and spine institute

Navi Mumbai, Maharashtra, India

Location

Related Publications (1)

  • Sharma A, Sane H, Gokulchandran N, Pai S, Kulkarni P, Ganwir V, Maheshwari M, Sharma R, Raichur M, Nivins S, Badhe P. An open-label proof-of-concept study of intrathecal autologous bone marrow mononuclear cell transplantation in intellectual disability. Stem Cell Res Ther. 2018 Jan 31;9(1):19. doi: 10.1186/s13287-017-0748-2.

    PMID: 29386049DERIVED

MeSH Terms

Conditions

Intellectual Disability

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2014

First Posted

September 22, 2014

Study Start

September 1, 2011

Primary Completion

March 1, 2016

Study Completion

September 1, 2016

Last Updated

October 25, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)