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Allogeneic Cord Blood for Neurological Diseases in Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05515419
Recruitment Status : Not yet recruiting
First Posted : August 25, 2022
Last Update Posted : November 2, 2022
Sponsor:
Information provided by (Responsible Party):
The Medical Pavilion Bahamas

Study Description
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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.

Condition or disease Intervention/treatment Phase
Neurological Diseases Stroke Spinal Cord Injuries Biological: Allogeneic cord blood treatment Early Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: allogeneic cord blood for adult patients with neurological diseases
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Allogeneic Cord Blood in the Treatment of Neurological Diseases in Adults
Estimated Study Start Date : January 3, 2023
Estimated Primary Completion Date : September 30, 2024
Estimated Study Completion Date : November 30, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Allogeneic cord blood therapy
Allogeneic cord blood therapy
 Biological: Allogeneic cord blood treatment
Allogeneic cord blood treatment


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05515419


Contacts
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Contact: Conville S Brown, MD 242-356-6666 ext 001 drconvillebrown@gmail.com
Contact: Corrine S Quee, MD 242-356-6666 ext 001 support@tmp-bahamas.com

Sponsors and Collaborators
The Medical Pavilion Bahamas
Investigators
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Principal Investigator: Conville S Brown, MD The Medical Pavilion Bahamas
More Information
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Responsible Party: The Medical Pavilion Bahamas
ClinicalTrials.gov Identifier: NCT05515419    
Other Study ID Numbers: 101
First Posted: August 25, 2022    Key Record Dates
Last Update Posted: November 2, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by The Medical Pavilion Bahamas:
Adults
Additional relevant MeSH terms:
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Spinal Cord Injuries
Nervous System Diseases
Spinal Cord Diseases
 Central Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries