NCT02245776

Brief Summary

The purpose of the study was to analyze the benefit of autologous mononuclear cell therapy in incurable neurological disorders.

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 Dec 2008

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withdrawn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

December 1, 2008

Completed
5.8 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
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

October 25, 2018

Status Verified

October 1, 2018

Enrollment Period

9.5 years

First QC Date

September 12, 2014

Last Update Submit

October 23, 2018

Conditions

Neurological; Disorder, Nervous System

Keywords

Incurable Neurological DisordersAutologous mononuclear cell therapyStem cells

Outcome Measures

Primary Outcomes (1)

  • Change in various clinical symptoms of neurological disorders

    Change in various symptoms such as muscle strength, limb strength, ambulation, neck holding, bladder bowel management, spasticity, sensation, speech, etc depending on the disorder will be recorded at 1 year follow up. Percentage analysis of each symptom will be carried out to study the benefits of stem cell therapy on them.

    1 year

Study Arms (1)

Stem Cell

EXPERIMENTAL

Bone marrow mononuclear cell transplantation

Biological: Stem Cell

Interventions

Stem CellBIOLOGICAL

Intrathecal autologous bone marrow mononuclear cell transplantation

Stem Cell

Eligibility Criteria

Age6 Months - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosed cases of incurable neurological disorders
  • 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
  • pregnancy
  • lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neurogen brain and spine institute

Navi Mumbai, Maharashtra, 400706, India

Location

MeSH Terms

Conditions

Neurologic Manifestations

Condition Hierarchy (Ancestors)

Nervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms
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

December 1, 2008

Primary Completion

June 1, 2018

Study Completion

December 1, 2018

Last Updated

October 25, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)