NCT02242071

Brief Summary

The effect of autologous bone marrow mononuclear cells on Motor Neuron Disease/Amyotrophic Lateral Sclerosis patients.

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withdrawn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
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1.5 years 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

6.2 years

First QC Date

September 12, 2014

Last Update Submit

October 23, 2018

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Motor Neuron DiseaseAmyotrophic Lateral SclerosisAutologous Mononuclear Cell therapyStem cells

Outcome Measures

Primary Outcomes (1)

  • Amyotrophic Lateral Sclerosis Functional rating scale-revised

    2 years

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

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with the diagnosis of definite Motor Neuron Disease/amyotrophic lateral sclerosis.
  • Age 18-80 years

You may not qualify if:

  • HIV/HBV/HCV
  • Malignancies
  • Bleeding tendencies
  • Pneumonia
  • Renal failure
  • Severe liver dysfunction
  • Severe anemia \[hb \< 8\]
  • Any bone marrow disorder
  • Space occupying lesion in brain
  • Pregnancy and lactation
  • Other acute medical conditions/infections such as respiratory infection and pyrexia
  • left ventricular ejection fraction \< 25%
  • Patient on artificial ventilatory support

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

Amyotrophic Lateral SclerosisMotor Neuron Disease

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases
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 16, 2014

Study Start

December 1, 2008

Primary Completion

March 1, 2015

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)