Neurological DiseasesEarly Phase 1NCT05515419
Allogeneic Cord Blood for Neurological Diseases in Adults
A Early Phase 1 study testing Allogeneic cord blood treatment in people with Neurological Diseases and Stroke, run by The Medical Pavilion Bahamas.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurological Diseases, Stroke, Spinal Cord Injuries
- What is being tested?
- Allogeneic cord blood treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 30 Nov 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ischemic or hemorrhagic stroke (onset < 24 months), or
- Spinal cord injury (onset < 24 months)
Who cannot join
- Raised intracranial pressure
- Malignant cancer
- Renal failure
- Severe pulmonary dysfunction
About this study
Official title: 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.
Read the 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.
- Conditions
- Neurological Diseases, Stroke, Spinal Cord Injuries
- Being tested
- Allogeneic cord blood treatment
- Keywords
- Adults
- Medical subject headings
- Stroke, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic cord blood treatmentBiological
Allogeneic cord blood treatment
| Study group | Role | What they receive |
|---|---|---|
| Allogeneic cord blood therapy | Experimental | Allogeneic cord blood therapy Receives: Biological: Allogeneic cord blood treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month - 3 months - 6 months - 12 months
Secondary outcomes (1)
Monitoring Adverse Events
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).
Measured: 1 month - 3 months - 6 months - 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start1 Jul 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Why it stopped: Due to regulatory reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurological DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- allogeneic cord blood for adult patients with neurological diseases
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Medical Pavilion Bahamas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Conville S Brown, MD, Principal investigator, The Medical Pavilion Bahamas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05515419
- Sponsor's protocol ID
- 101
- Status last verified
- Sep 2025
- First submitted
- 18 Aug 2022
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogeneic Cord Blood in the Treatment of Neurological Diseases in Adults
- ClinicalTrials.gov ID
- NCT05515419
- Acronym / sponsor ID
- 101
- Conditions
- Neurological Diseases, Stroke, Spinal Cord Injuries
- Keywords
- Adults
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to regulatory reasons
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Medical Pavilion BahamasUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 25 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- allogeneic cord blood for adult patients with neurological diseases
| Arm | Type | Receives |
|---|---|---|
| Allogeneic cord blood therapy | Experimental | Biological: Allogeneic cord blood treatmentAllogeneic cord blood therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ischemic or hemorrhagic stroke (onset < 24 months), or
- Spinal cord injury (onset < 24 months)
Key exclusion criteria (4 listed)
- Raised intracranial pressure
- Malignant cancer
- Renal failure
- Severe pulmonary dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allogeneic cord blood treatmentAllogeneic cord blood treatment | Biological | Allogeneic cord blood therapy |
Primary outcome
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 secondary outcome
Monitoring Adverse Events
Time frame: 1 month - 3 months - 6 months - 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Conville S Brown, MD principal investigator
The Medical Pavilion Bahamas
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Allogeneic cord blood treatment in people with Neurological Diseases and Stroke, run by The Medical Pavilion Bahamas.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in modified Rankin Scale (mRS) (time frame: 1 month - 3 months - 6 months - 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.