Cell Therapy for Motor Neuron Disease/Amyotrophic Lateral Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02242071
• Date of registration: 12/09/2014
• Prospective Registration: No
• Primary sponsor: Neurogen Brain and Spine Institute
• Public title: Cell Therapy for Motor Neuron Disease/Amyotrophic Lateral Sclerosis
• Scientific title: The Effect of Autologous Bone Marrow Mononuclear Cell Transplantation on Motor Neuron Disease/Amyotrophic Lateral Sclerosis
• Date of first enrolment: December 2008
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT02242071
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

India

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Amyotrophic Lateral Sclerosis

Intervention(s)

Biological: Stem Cell

Primary Outcome(s)

Amyotrophic Lateral Sclerosis Functional rating scale-revised [Time Frame: 2 years]

Secondary ID(s)

NGBSI-10

Source(s) of Monetary Support

Please refer to primary and secondary sponsors