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NCT02242071 Clinical Trial

Cell Therapy for Motor Neuron Disease/Amyotrophic Lateral Sclerosis

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:
The Effect of Autologous Bone Marrow Mononuclear Cell Transplantation on Motor Neuron Disease/Amyotrophic Lateral Sclerosis

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02242071
Other study ID # NGBSI-10
Secondary ID
Status Withdrawn
Phase Phase 1
First received
Last updated
Start date December 2008
Est. completion date September 2016

Study information
Verified date October 2018
Source Neurogen Brain and Spine Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date September 2016
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Patients with the diagnosis of definite Motor Neuron Disease/amyotrophic lateral sclerosis.

- Age 18-80 years

Exclusion Criteria:

- 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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Stem Cell
intrathecal autologous bone marrow mononuclear cell transplantation

Locations
Country Name City State
India Neurogen brain and spine institute Navi Mumbai Maharashtra

Sponsors (1)
Lead Sponsor Collaborator
Neurogen Brain and Spine Institute

Country where clinical trial is conducted

India, 

Outcome
Type Measure Description Time frame Safety issue
Primary Amyotrophic Lateral Sclerosis Functional rating scale-revised 2 years
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