Lomecel-B Effects on Alzheimer's Disease
Public ClinicalTrials.gov record NCT05233774. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Lomecel-B Effects on Alzheimer's Disease: A Randomized, Double-Blinded, Placebo-Controlled Phase 2a Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Dementia resulting from AD is associated with vascular function decline and involves a pro-inflammatory state. In our Phase 1 trial, Lomecel-B treatment met the primary safety endpoint, with no safety concerns, and showed potential to improve clinical assessments. Mechanistically, Lomecel-B treated subjects had higher serum concentrations of pro-vascular and anti-inflammatory biomarkers relative to placebo. This trial builds upon those preliminary Phase 1 results, and is designed to evaluate the safety profile of multiple infusions of Lomecel-B, and to investigate provisional efficacy of single dosing versus multiple dosing of Lomecel-B on cognitive function and biomarkers in AD subjects.
Study identification
- NCT ID
- NCT05233774
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 50 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 60 Years to 85 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 28, 2021 (Actual)
- Primary completion
- Sep 29, 2023 (Actual)
- Completion
- Sep 29, 2023 (Actual)
- Last update posted
- Feb 20, 2024
2021 – 2023
United States locations
- U.S. sites
- 13
- U.S. states
- 1
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Visionary Investigators Network | Aventura | Florida | 33180 | — |
| Brain Matters Research | Delray Beach | Florida | 33445 | — |
| Science Connections - Research Partner Group Multispecialty Group | Doral | Florida | 33178 | — |
| Bruce W. Carter VA Medical Center | Miami | Florida | 33125 | — |
| Miami Jewish Health | Miami | Florida | 33137 | — |
| Allied Biomedical Research Institute | Miami | Florida | 33155 | — |
| Ivetmar Medical Group | Miami | Florida | 33155 | — |
| Fusion Medical Research and Clinic | Miami | Florida | 33173 | — |
| First Excellent Research Group, LLC | Miami | Florida | 33175 | — |
| Brainstorm Research | Miami | Florida | 33176 | — |
| Miami Dade Medical Research Institute | Miami | Florida | 33176 | — |
| Imic Inc. | Palmetto Bay | Florida | 33157 | — |
| Brain Matters Research | Stuart | Florida | 34997 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05233774, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 20, 2024 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05233774 live on ClinicalTrials.gov.