Cell Therapy for Motor Neuron Disease/Amyotrophic Lateral Sclerosis

Phase 1

Withdrawn

• Conditions: Amyotrophic Lateral Sclerosis
• Interventions: Biological: Stem Cell

• Registration Number: NCT02242071
• Lead Sponsor: Neurogen Brain and Spine Institute

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2014-09-12
• Study First Submitted QC: 2014-09-13
• Study First Posted: 2014-09-16
• Primary Completion: 2015-03
• Study Completion: 2016-09
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-23
• Last Update Posted: 2018-10-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stem Cell	Stem Cell	bone marrow mononuclear cell transplantation

Primary Outcome Measures

Name	Time	Method
Amyotrophic Lateral Sclerosis Functional rating scale-revised	2 years

Trial Locations

Locations (1)

Neurogen brain and spine institute; 🇮🇳 Navi Mumbai, Maharashtra, India