NCT05515419

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.

Trial Health

45
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
7mo left

Started Jul 2025

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
Jul 2025Nov 2026

First Submitted

Initial submission to the registry

August 18, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 25, 2022

Completed
2.9 years until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

September 10, 2025

Status Verified

September 1, 2025

Enrollment Period

1.2 years

First QC Date

August 18, 2022

Last Update Submit

September 3, 2025

Conditions

Neurological DiseasesStrokeSpinal Cord Injuries

Keywords

Adults

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Monitoring Adverse Events

    1 month - 3 months - 6 months - 12 months

Study Arms (1)

Allogeneic cord blood therapy

EXPERIMENTAL

Allogeneic cord blood therapy

Biological: Allogeneic cord blood treatment

Interventions

Allogeneic cord blood treatmentBIOLOGICAL

Allogeneic cord blood treatment

Allogeneic cord blood therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ischemic or hemorrhagic stroke (onset \< 24 months), or
  • Spinal cord injury (onset \< 24 months)

You may not qualify if:

  • Raised intracranial pressure
  • Malignant cancer
  • Renal failure
  • Severe pulmonary dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

StrokeSpinal Cord Injuries

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesSpinal Cord DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Conville S Brown, MD

    The Medical Pavilion Bahamas

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: allogeneic cord blood for adult patients with neurological diseases
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2022

First Posted

August 25, 2022

Study Start

July 1, 2025

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

September 10, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share