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
• Status: Not yet recruiting
• Phase: Early Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Nervous System Diseases
• Neurological Diseases
• Spinal Cord Injuries
• Stroke

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