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NCT05515419 Clinical Trial

Allogeneic Cord Blood for Neurological Diseases in Adults

Stroke Clinical Trial

Official title:
Allogeneic Cord Blood in the Treatment of Neurological Diseases in Adults

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05515419
Other study ID # 101
Secondary ID
Status Not yet recruiting
Phase Early Phase 1
First received
Last updated
Start date July 1, 2024
Est. completion date November 30, 2024

Study information
Verified date April 2024
Source The Medical Pavilion Bahamas
Contact Conville S Brown, MD
Phone 242-356-6666
Email drconvillebrown@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 80
Est. completion date November 30, 2024
Est. primary completion date September 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Allogeneic cord blood treatment
Allogeneic cord blood treatment

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
The Medical Pavilion Bahamas

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in modified Rankin Scale (mRS) 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. 1 month - 3 months - 6 months - 12 months
Secondary Monitoring Adverse Events 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). 1 month - 3 months - 6 months - 12 months
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