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Allogeneic Cord Blood for Neurological Diseases in Adults

Sponsor
The Medical Pavilion Bahamas (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05515419
Collaborator
(none)
80
Enrollment
1
Arm
27
Anticipated Duration (Months)

Study Details

Study Description

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
  • 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

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
allogeneic cord blood for adult patients with neurological diseasesallogeneic 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
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Sep 30, 2024
Anticipated Study Completion Date :
Nov 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Allogeneic cord blood therapy

Allogeneic cord blood therapy

Biological: Allogeneic cord blood treatment
Allogeneic cord blood treatment

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

No locations specified.

Sponsors and Collaborators

  • The Medical Pavilion Bahamas

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The Medical Pavilion Bahamas
ClinicalTrials.gov Identifier:
NCT05515419
Other Study ID Numbers:
  • 101
First Posted:
Aug 25, 2022
Last Update Posted:
Aug 25, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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:
Spinal Cord Injuries
Nervous System Diseases

Study Results

No Results Posted as of Aug 25, 2022