search
Back to results

Stem Cell Therapy in Mental Retardation

Primary Purpose

Mental Retardation

Status
Withdrawn
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
Stem Cell
Sponsored by
Neurogen Brain and Spine Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mental Retardation focused on measuring Mental retardation, Autologous mononuclear cell therapy, Stem cell

Eligibility Criteria

6 Months - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • diagnosed cases of mental retardation
  • age above 6 months

Exclusion Criteria:

  • 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

Sites / Locations

  • Neurogen brain and spine institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stem Cell

Arm Description

Bone marrow mononuclear cell transplantation

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 12, 2014
Last Updated
October 23, 2018
Sponsor
Neurogen Brain and Spine Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT02245724
Brief Title
Stem Cell Therapy in Mental Retardation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Withdrawn
Study Start Date
September 2011 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neurogen Brain and Spine Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Retardation
Keywords
Mental retardation, Autologous mononuclear cell therapy, Stem cell

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stem Cell
Arm Type
Experimental
Arm Description
Bone marrow mononuclear cell transplantation
Intervention Type
Biological
Intervention Name(s)
Stem Cell
Intervention Description
Autologous bone marrow mononuclear cell transplantation
Primary Outcome Measure Information:
Title
Change in common clinical symptoms of mental retardation
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosed cases of mental retardation age above 6 months Exclusion Criteria: 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
Facility Information:
Facility Name
Neurogen brain and spine institute
City
Navi Mumbai
State/Province
Maharashtra
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29386049
Citation
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.
Results Reference
derived

Learn more about this trial

Stem Cell Therapy in Mental Retardation

We'll reach out to this number within 24 hrs