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Longeveron

🇺🇸United States
Ownership
-
Employees
25
Market Cap
$32.7M
Website

Clinical Trials

10

Active:3
Completed:5

Trial Phases

2 Phases

Phase 1:6
Phase 2:4

Drug Approvals

0

Drug Approvals

No drug approvals found

This company may not have drug approvals in our database

Clinical Trials

Distribution across different clinical trial phases (10 trials with phase data)• Click on a phase to view related trials

Phase 1
6 (60.0%)
Phase 2
4 (40.0%)

Lomecel-B Effects on Alzheimer's Disease

Phase 2
Completed
Conditions
Mild Alzheimer's Disease
Interventions
Other: Placebo
Drug: Allogeneic MSC
First Posted Date
2022-02-10
Last Posted Date
2024-02-20
Lead Sponsor
Longeveron Inc.
Target Recruit Count
50
Registration Number
NCT05233774
Locations
🇺🇸

Visionary Investigators Network, Aventura, Florida, United States

🇺🇸

Brain Matters Research, Stuart, Florida, United States

🇺🇸

Science Connections - Research Partner Group Multispecialty Group, Doral, Florida, United States

and more 9 locations

Evaluation of Lomecel-B™ Injection in Patients With Hypoplastic Left Heart Syndrome (HLHS): A Phase IIb Clinical Trial.

Phase 2
Active, not recruiting
Conditions
Hypoplastic Left Heart Syndrome
Interventions
Biological: Lomecel-B medicinal signaling cells
First Posted Date
2021-06-14
Last Posted Date
2025-06-25
Lead Sponsor
Longeveron Inc.
Target Recruit Count
40
Registration Number
NCT04925024
Locations
🇺🇸

Children's Hospital of Los Angeles, Los Angeles, California, United States

🇺🇸

Children's Hospital Colorado, Aurora, Colorado, United States

🇺🇸

Children's Healthcare of Atlanta, Atlanta, Georgia, United States

and more 7 locations

Regenerative Medicine for COVID-19 and Flu-Elicited ARDS Using Lomecel-B (RECOVER)

Phase 1
Active, not recruiting
Conditions
ARDS, Human
Covid19
First Posted Date
2020-11-16
Last Posted Date
2024-02-20
Lead Sponsor
Longeveron Inc.
Target Recruit Count
70
Registration Number
NCT04629105
Locations
🇺🇸

Miami VA Healthcare System, Miami, Florida, United States

🇺🇸

University of Maryland Medical Center, Baltimore, Maryland, United States

🇺🇸

Wake Forest Baptist Medical Center, Winston-Salem, North Carolina, United States

Lomecel-B Delivered During Stage II Surgery for Hypoplastic Left Heart Syndrome (ELPIS)

Phase 1
Active, not recruiting
Conditions
HLHS
First Posted Date
2018-05-15
Last Posted Date
2023-10-04
Lead Sponsor
Longeveron Inc.
Target Recruit Count
10
Registration Number
NCT03525418
Locations
🇺🇸

Emory University/Childen's Healthcare of Atlanta, Atlanta, Georgia, United States

🇺🇸

University of Maryland Medical Center, Baltimore, Maryland, United States

🇺🇸

Johns Hopkins University Hospital, Baltimore, Maryland, United States

and more 2 locations

Phase IIb Trial to Evaluate Longeveron Mesenchymal Stem Cells to Treat Aging Frailty

Phase 2
Completed
Conditions
Aging Frailty
First Posted Date
2017-05-30
Last Posted Date
2022-03-07
Lead Sponsor
Longeveron Inc.
Target Recruit Count
150
Registration Number
NCT03169231
Locations
🇺🇸

Soffer Health Institute, Aventura, Florida, United States

🇺🇸

Clinical Research of South Florida, Coral Gables, Florida, United States

🇺🇸

Clinical Physiology Associates, Fort Myers, Florida, United States

and more 4 locations
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News

Longeveron Appoints Than Powell as Chief Business Officer to Lead Alzheimer's and HLHS Program Strategy

Longeveron Inc. has appointed Than Powell as Chief Business Officer effective July 7, 2025, to oversee partnering efforts for Alzheimer's disease and international strategy for hypoplastic left heart syndrome programs.

Longeveron's Laromestrocel Shows Promise in Phase 2a Trial for Mild Alzheimer's Disease

Longeveron's Phase 2a CLEAR MIND trial demonstrated that laromestrocel (formerly Lomecel-B) is safe and well-tolerated in patients with mild Alzheimer's disease, with no reported cases of amyloid-related imaging abnormalities.

Longeveron's Lomecel-B Nears Full Enrollment in Pivotal HLHS Trial, Shows Promise in Pediatric Heart Disease

Longeveron's Phase 2b ELPIS II trial for Lomecel-B in Hypoplastic Left Heart Syndrome has reached 90% enrollment, with completion expected in Q2 2025 and potential BLA submission in 2026.

Longeveron's Lomecel-B Shows Promise in HLHS and Alzheimer's Disease Trials

Longeveron's ELPIS II trial for HLHS, evaluating Lomecel-B™, has surpassed 80% enrollment and is deemed pivotal by the FDA for BLA submission.

Longeveron's Lomecel-B Shows Promise in Mild Alzheimer's Disease by Targeting MMP14

Longeveron presented data at CTAD24 showing Lomecel-B's potential in treating mild Alzheimer's by inhibiting MMP14, offering mechanistic and clinical insights.

Longeveron's Lomecel-B Shows Long-Term Survival Benefit in HLHS Patients

Longeveron presented data showing 100% five-year transplant-free survival in HLHS patients treated with Lomecel-B in the ELPIS I study, following Glenn surgery.

Longeveron's Lomecel-B Shows Long-Term Survival Benefit in HLHS Patients

Lomecel-B demonstrated 100% five-year transplant-free survival in HLHS patients post-Glenn surgery in the ELPIS I follow-up study, compared to 83% in the SVR trial.

Longeveron's Lomecel-B Data in Alzheimer's Disease to be Presented at CTAD24

Longeveron's Lomecel-B data, focusing on MMP14 inhibition, will be presented at the Clinical Trials on Alzheimer's Disease Conference (CTAD24).

Longeveron's Lomecel-B Shows Promising 5-Year Transplant-Free Survival in HLHS Patients

Longeveron's Lomecel-B demonstrates improved long-term transplant-free survival in infants with Hypoplastic Left Heart Syndrome (HLHS) over five years.

Cell and Gene Therapies Emerge as Promising Avenues for Alzheimer's Disease Treatment

• Several cell and gene therapies are under investigation for Alzheimer's disease, with some showing early signs of efficacy in clinical trials. • NKGen's SNK01, an autologous NK cell therapy, demonstrated encouraging clinical activity and tolerability in a Phase 1 trial, with improvements in ADCOMS scores and CSF α-syn levels. • Longeveron's Lomecel-B, an allogeneic MSC therapy, showed statistically significant improvements in ADCS-ADL scores and trends of improvement on MMSE in a Phase 2 trial. • Beyond amyloid-targeting antibodies, researchers are exploring diverse targets like tau, inflammation, and viral proteins, with drug repurposing strategies also gaining traction.

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