Allogeneic Cord Blood for Neurological Diseases in Adults

Early Phase 1

Not yet recruiting

• Conditions: Spinal Cord Injuries; Neurological Diseases; Stroke
• Interventions: Biological: Allogeneic cord blood treatment

• Registration Number: NCT05515419
• Lead Sponsor: The Medical Pavilion Bahamas

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.

Study Timeline

• Study First Submitted: 2022-08-18
• Study First Submitted QC: 2022-08-24
• Study First Posted: 2022-08-25
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-11
• Study Start: 2025-07-01
• Primary Completion: 2026-09-30
• Study Completion: 2026-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Allogeneic cord blood therapy	Allogeneic cord blood treatment	Allogeneic cord blood therapy

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).