Neurological Diseases, Spinal Cord Injuries, Stroke
Conditions
Keywords
Adults
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.
Interventions
Allogeneic cord blood treatment
Sponsors
Study design
Intervention model description
allogeneic cord blood for adult patients with neurological diseases
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in modified Rankin Scale (mRS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Monitoring Adverse Events | 1 month - 3 months - 6 months - 12 months | Number of participants with treatment-related adverse events as assessedCommon by Toxicity Criteria for Adverse Events (CTCAE).version 5.0; adverse events are graded on a scale from 0 to 5, whereby grade 0 is best (no AE) and grade 5 is worst (fatal). |