Allogeneic Cord Blood for Neurological Diseases in Adults

September 3, 2025 updated by: The Medical Pavilion Bahamas

Allogeneic Cord Blood in the Treatment of Neurological Diseases in Adults

This open label trial is conducted to investigate the efficacy and safety of allogeneic umbilical cord blood therapy for adult patients with neurological diseases.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Allogeneic cord blood therapy
Biological: Allogeneic cord blood treatment
Allogeneic cord blood treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 month - 3 months - 6 months - 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Monitoring Adverse Events
Time Frame: 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).
1 month - 3 months - 6 months - 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Medical Pavilion Bahamas

Investigators

  • Principal Investigator: Conville S Brown, MD, The Medical Pavilion Bahamas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2025

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

August 18, 2022

First Submitted That Met QC Criteria

August 24, 2022

First Posted (Actual)

August 25, 2022

Study Record Updates

Last Update Posted (Estimated)

September 10, 2025

Last Update Submitted That Met QC Criteria

September 3, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 101 (Other Identifier: Hamilton Integrated Research Ethics Board)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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