Allogeneic Cord Blood in the Treatment of Neurological Diseases in Adults
Overview
- Phase
- Early Phase 1
- Intervention
- Allogeneic cord blood treatment
- Conditions
- Neurological Diseases
- Sponsor
- The Medical Pavilion Bahamas
- Enrollment
- 80
- Primary Endpoint
- Changes in modified Rankin Scale (mRS)
- Status
- Withdrawn
- Last Updated
- 7 months ago
Overview
Brief Summary
This open label trial is conducted to investigate the efficacy and safety of allogeneic umbilical cord blood therapy for adult patients with neurological diseases.
Detailed Description
Neurological diseases such as stroke or spinal cord injuries are very common etiologies causing disability in developed countries. Cord blood possess various stem and progenitor cells, as well as their secreted regenerative factors, and is known to repair injured brain. The investigators clinical research aims to determine the safety and efficacy of allogeneic Umbilical Cord Blood for adult patients with neurological diseases such as stroke and spinal cord injury.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Ischemic or hemorrhagic stroke (onset \< 24 months), or
- •Spinal cord injury (onset \< 24 months)
Exclusion Criteria
- •Raised intracranial pressure
- •Malignant cancer
- •Renal failure
- •Severe pulmonary dysfunction
Arms & Interventions
Allogeneic cord blood therapy
Allogeneic cord blood therapy
Intervention: Allogeneic cord blood treatment
Outcomes
Primary Outcomes
Changes in modified Rankin Scale (mRS)
Time Frame: 1 month - 3 months - 6 months - 12 months
modified Rankin Scale (mRS) from 1 - 5 whereby 1 is best (no significant disability) and 5 is worst (severe disability); The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.
Secondary Outcomes
- Monitoring Adverse Events(1 month - 3 months - 6 months - 12 months)