Autologous Bone Marrow-Derived Stem Cell Therapy for Motor Neuron Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03067857
• Date of registration: 25/02/2017
• Prospective Registration: No
• Primary sponsor: Stem Cells Arabia
• Public title: Autologous Bone Marrow-Derived Stem Cell Therapy for Motor Neuron Disease
• Scientific title: Autologous Purified Bone-Marrow-Derived Stem Cell Therapy for Motor Neuron Disease
• Date of first enrolment: September 2016
• Target sample size: 40
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT03067857
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients age 24-20 years old

- Patients with the diagnosis of definite Motor Neuron Disease

Exclusion Criteria:

- HIV/HBV/HCV

- Malignancies

- Bleeding

- Pneumonia

- Renal failure

- liver dysfunction

- Severe anemia (hb < 8)

- Bone Marrow diseases

- Pregnancy and lactation

- Acute medical conditions/infections such as respiratory infections

- ventilatory support



Age minimum: 24 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Progressive Bulbar Palsies

Primary Lateral Sclerosis

Motor Neuron Disease

Amyotrophic Lateral Sclerosis

Progressive Muscular Atrophy

Intervention(s)

Biological: Stem Cells

Primary Outcome(s)

Changes in Functional Rating Scale - via questionnaire [Time Frame: 6 months]

Secondary Outcome(s)

Change in SF-36 (The Short Form (36) Health Survey is a 36 Item) [Time Frame: 4 months]

Change in Forced Vital Capacity (FVC) [Time Frame: 4 months]

Change in Appel Scale [Time Frame: 4 months]

Secondary ID(s)

SCA-MND1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors