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- | Lomecel-B (laromestrocel) / Longeveron
Trial completion date, Trial primary completion date: ELPISII: Evaluation of Lomecel-B (clinicaltrials.gov) - Feb 12, 2025
P2, N=38, Recruiting, Sponsor: Longeveron Inc.
Trial completion date: Aug 2026 --> Aug 2025 | Trial primary completion date: Jun 2026 --> Jun 2025
- | Lomecel-B (laromestrocel) / Longeveron
Trial completion date, Trial primary completion date: ELPISII: Evaluation of Lomecel-B (clinicaltrials.gov) - Feb 6, 2025
P2, N=38, Recruiting, Sponsor: Longeveron Inc.
Trial completion date: Aug 2026 --> Aug 2025 | Trial primary completion date: Jun 2026 --> Jun 2025 Trial primary completion date: Mar 2025 --> Jun 2026 | Trial completion date: Aug 2025 --> Aug 2026
- | Lomecel-B (Longeveron mesenchymal stem cells) / Longeveron
Journal: Drug Development. (Pubmed Central) - Jan 12, 2025
P2
Brain MRI in this proof-of-concept study with small sample size reveals that Lomecel-B was associated with measurable neuroanatomical and neuroinflammatory improvements compared with progressive AD pathology observed in placebo. Accordingly, these findings support further development of Lomecel-B in a larger dose-finding study.
- | Lomecel-B (Longeveron mesenchymal stem cells) / Longeveron
Journal: Drug Development. (Pubmed Central) - Jan 12, 2025
P2
Together, the study achieved proof-of-concept in a small sample size. Accordingly, these findings support further development of Lomecel-B in a larger dose-finding study.
- Lomecel-B (Longeveron mesenchymal stem cells) / Longeveron
Lomecel-B inhibition of MMP14 activity predicts Lomecel-B bioactivity in the treatment of mild Alzheimer's disease () - Sep 24, 2024 - Abstract #CTAD2024CTAD_420;
- || Lomecel-B (Longeveron mesenchymal stem cells) / Longeveron
Review, Journal: A systematic review of clinical efficacy and safety of cell-based therapies in Alzheimer's disease. (Pubmed Central) - Sep 11, 2024
Also, there is considerable risk of bias regarding the outcome assessment scales. Cell-based therapies are well tolerated by AD patients, which emphasizes the need for further, carefully planned randomized studies to reach evidence-based clinical recommendations in this respect.
- Lomecel-B (Longeveron mesenchymal stem cells) / Longeveron
Reduction in Alzheimer (Exhibit (Pennsylvania Convention Center); In-Person) - Jun 19, 2024 - Abstract #AAIC2024AAIC_3652;
P2
Conclusion : Brain MRI in this proof-of-concept study with small sample size reveals that Lomecel-B was associated with measurable neuroanatomical and neuroinflammatory improvements compared with progressive AD pathology observed in placebo. Accordingly, these findings support further development of Lomecel-B in a larger dose-finding study.
- Lomecel-B (Longeveron mesenchymal stem cells) / Longeveron
Results from a Phase 2a Proof-of-Concept Double-Blind, Randomized, Placebo-Controlled Trial of Lomecel-BTM in Mild Alzheimer (201 ABC (Pennsylvania Convention Center)) - Jun 19, 2024 - Abstract #AAIC2024AAIC_2434;
P2
Together, the study achieved proof-of-concept in a small sample size. Accordingly, these findings support further development of Lomecel-B in a larger dose-finding study.
- Lomecel-B (laromestrocel) / Longeveron
Phase classification: ELPISII: Evaluation of Lomecel-B (clinicaltrials.gov) - Feb 20, 2024
P2, N=38, Recruiting, Sponsor: Longeveron Inc.
Accordingly, these findings support further development of Lomecel-B in a larger dose-finding study. Phase classification: P2b --> P2
- || Lomecel-B (laromestrocel) / Longeveron
Trial completion, Phase classification: CLEARMIND: Lomecel-B Effects on Alzheimer's Disease (clinicaltrials.gov) - Feb 19, 2024
P2, N=50, Completed, Sponsor: Longeveron Inc.
Phase classification: P2b --> P2 Active, not recruiting --> Completed | Phase classification: P2a --> P2
- || Lomecel-B (laromestrocel) / Longeveron
Trial primary completion date: Regenerative Medicine for COVID-19 and Flu-Elicited ARDS Using Lomecel-B (RECOVER) (clinicaltrials.gov) - Feb 19, 2024
P1, N=70, Active, not recruiting, Sponsor: Longeveron Inc.
Active, not recruiting --> Completed | Phase classification: P2a --> P2 Trial primary completion date: Jan 2024 --> Jun 2024
- Lomecel-B (laromestrocel) / Longeveron
Trial primary completion date: Lomecel-B Delivered During Stage II Surgery for Hypoplastic Left Heart Syndrome (ELPIS) (clinicaltrials.gov) - Oct 4, 2023
P1/2, N=10, Active, not recruiting, Sponsor: Longeveron Inc.
Trial primary completion date: Jan 2024 --> Jun 2024 Trial primary completion date: Dec 2021 --> Jun 2024
- || Lomecel-B (laromestrocel) / Longeveron
Trial primary completion date: Regenerative Medicine for COVID-19 and Flu-Elicited ARDS Using Lomecel-B (RECOVER) (clinicaltrials.gov) - Oct 4, 2023
P1, N=70, Active, not recruiting, Sponsor: Longeveron Inc.
Trial primary completion date: Dec 2021 --> Jun 2024 Trial primary completion date: Aug 2023 --> Jan 2024
- Lomecel-B (laromestrocel) / Longeveron
Enrollment closed, Trial completion date: Lomecel-B Delivered During Stage II Surgery for Hypoplastic Left Heart Syndrome (ELPIS) (clinicaltrials.gov) - May 1, 2023
P1/2, N=10, Active, not recruiting, Sponsor: Longeveron Inc.
Trial primary completion date: Aug 2023 --> Jan 2024 Completed --> Active, not recruiting | Trial completion date: Dec 2021 --> Dec 2025
- | Lomecel-B (laromestrocel) / Longeveron
Enrollment closed: CLEARMIND: Lomecel-B Effects on Alzheimer's Disease (clinicaltrials.gov) - Apr 28, 2023
P2a, N=48, Active, not recruiting, Sponsor: Longeveron Inc.
Completed --> Active, not recruiting | Trial completion date: Dec 2021 --> Dec 2025 Recruiting --> Active, not recruiting
- || Lomecel-B (laromestrocel) / Longeveron
Enrollment closed: Regenerative Medicine for COVID-19 and Flu-Elicited ARDS Using Lomecel-B (RECOVER) (clinicaltrials.gov) - Apr 28, 2023
P1, N=70, Active, not recruiting, Sponsor: Longeveron Inc.
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- || Lomecel-B (Longeveron mesenchymal stem cells) / Longeveron
Review, Journal: Recent clinical trials with stem cells to slow or reverse normal aging processes. (Pubmed Central) - Apr 24, 2023
In addition to aesthetic purposes, clinical research on facial skin aging allows direct evaluation of tissue regeneration using sophisticated and precise methods. Therefore, research on both conditions is complementary, which facilitates a global vision.
- || Lomecel-B (Longeveron mesenchymal stem cells) / Longeveron
P1 data, Journal: Intramyocardial cell-based therapy with Lomecel-B during bidirectional cavopulmonary anastomosis for hypoplastic left heart syndrome: the ELPIS phase I trial. (Pubmed Central) - Mar 25, 2023
P1/2
Circulating exosomes of transplanted MSC-specific provide novel insight into bioactivity. Conduct of a controlled phase trial is warranted and is underway.Trial registration number NCT03525418.
- | Lomecel-B (laromestrocel) / Longeveron
Enrollment change, Trial withdrawal: Safety and Efficacy Trial Using Allogeneic Human Mesenchymal Stem Cells: The SIRONA Trial (clinicaltrials.gov) - Feb 16, 2023
P2, N=0, Withdrawn, Sponsor: Longeveron Inc.
Conduct of a controlled phase trial is warranted and is underway.Trial registration number NCT03525418. N=40 --> 0 | Not yet recruiting --> Withdrawn
- | Lomecel-B (laromestrocel) / Longeveron
Trial completion date: HERA: Lomecel-B on Vaccine-Specific Antibody- Response in Subjects With Aging Frailty (clinicaltrials.gov) - Nov 4, 2022
P1/2, N=62, Completed, Sponsor: Longeveron Inc.
N=40 --> 0 | Not yet recruiting --> Withdrawn Trial completion date: Jun 2022 --> Sep 2022
- Lomecel-B (Longeveron mesenchymal stem cells) / Longeveron
Lomecel-B as a Geroscience Therapeutic Candidate for Dementia and Frailty () - Oct 5, 2022 - Abstract #CTAD2022CTAD_54;
- Lomecel-B (Longeveron mesenchymal stem cells) / Longeveron
The Effects of Multiple Doses of Lomecel-B, Longeveron’ s Cell-based Therapy, on Alzheimer’s disease: Study Design and Rationale of this Phase 2a Multi- center Clinical trial. () - Jun 24, 2022 - Abstract #AAIC2022AAIC_869;
- ||| Lomecel-B (laromestrocel) / Longeveron
Trial completion: HERA: Lomecel-B on Vaccine-Specific Antibody- Response in Subjects With Aging Frailty (clinicaltrials.gov) - Jun 3, 2022
P1/2, N=62, Completed, Sponsor: Longeveron Inc.
Trial completion date: Jun 2022 --> Sep 2022 Active, not recruiting --> Completed
- || Lomecel-B (Longeveron mesenchymal stem cells) / Longeveron
Biomarker, Clinical, P2b data, Journal: The Design and Rationale of a Phase 2b, Randomized, Double-Blinded, and Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Lomecel-B in Older Adults with Frailty. (Pubmed Central) - Apr 27, 2022
This clinical trial investigates the use of a regenerative medicine strategy for frailty in older adults. The results will further the understanding of the potential for Lomecel-B in the geriatric condition of frailty.
- || Lomecel-B (Longeveron mesenchymal stem cells) / Longeveron
P1 data, Journal: Results and insights from a phase I clinical trial of Lomecel-B for Alzheimer's disease. (Pubmed Central) - Apr 1, 2022
Our results support the safety of Lomecel-B for AD, suggest clinical potential, and provide mechanistic insights. This early-stage study provides important exploratory information for larger efficacy-powered clinical trials.
- | Lomecel-B (laromestrocel) / Longeveron
Trial completion date, Trial primary completion date: Safety and Efficacy Trial Using Allogeneic Human Mesenchymal Stem Cells: The SIRONA Trial (clinicaltrials.gov) - Mar 7, 2022
P2, N=40, Not yet recruiting, Sponsor: Longeveron Inc.
This early-stage study provides important exploratory information for larger efficacy-powered clinical trials. Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Dec 2023
- ||| Lomecel-B (laromestrocel) / Longeveron
Trial completion, Enrollment change, Trial primary completion date: Lomecel-B Delivered During Stage II Surgery for Hypoplastic Left Heart Syndrome (ELPIS) (clinicaltrials.gov) - Mar 7, 2022
P1/2, N=10, Completed, Sponsor: Longeveron Inc.
Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Dec 2023 Active, not recruiting --> Completed | N=30 --> 10 | Trial primary completion date: Dec 2020 --> Dec 2021
- | Lomecel-B (laromestrocel) / Longeveron
Trial completion date: HERA: Lomecel-B on Vaccine-Specific Antibody- Response in Subjects With Aging Frailty (clinicaltrials.gov) - Mar 7, 2022
P1/2, N=83, Active, not recruiting, Sponsor: Longeveron Inc.
Active, not recruiting --> Completed | N=30 --> 10 | Trial primary completion date: Dec 2020 --> Dec 2021 Trial completion date: Dec 2021 --> Apr 2022
- ||| Lomecel-B (laromestrocel) / Longeveron
Trial completion, Trial primary completion date: Phase IIb Trial to Evaluate Longeveron Mesenchymal Stem Cells to Treat Aging Frailty (clinicaltrials.gov) - Mar 7, 2022
P2b, N=150, Completed, Sponsor: Longeveron Inc.
Trial completion date: Dec 2021 --> Apr 2022 Active, not recruiting --> Completed | Trial primary completion date: Apr 2021 --> Sep 2021
- || Lomecel-B (laromestrocel) / Longeveron
New P2a trial: CLEARMIND: Lomecel-B Effects on Alzheimer's Disease (clinicaltrials.gov) - Feb 9, 2022
P2a, N=48, Recruiting, Sponsor: Longeveron Inc.
- || Lomecel-B (laromestrocel) / Longeveron
Trial completion: Lomecel-B Infusion Versus Placebo in Patients With Alzheimer's Disease (clinicaltrials.gov) - Dec 14, 2021
P1, N=33, Completed, Sponsor: Longeveron Inc.
Active, not recruiting --> Completed | Trial primary completion date: Apr 2021 --> Sep 2021 Active, not recruiting --> Completed
- | Lomecel-B (laromestrocel) / Longeveron
Trial completion date: Lomecel-B Delivered During Stage II Surgery for Hypoplastic Left Heart Syndrome (ELPIS) (clinicaltrials.gov) - Dec 14, 2021
P1/2, N=30, Active, not recruiting, Sponsor: Longeveron Inc.
Active, not recruiting --> Completed Trial completion date: Sep 2021 --> Dec 2021
- | Lomecel-B (laromestrocel) / Longeveron
Trial completion date: HERA: Lomecel-B on Vaccine-Specific Antibody- Response in Subjects With Aging Frailty (clinicaltrials.gov) - Sep 30, 2021
P1/2, N=83, Active, not recruiting, Sponsor: Longeveron Inc.
Trial completion date: Sep 2021 --> Dec 2021 Trial completion date: Aug 2021 --> Dec 2021
- || Lomecel-B (laromestrocel) / Longeveron
Trial primary completion date: Regenerative Medicine for COVID-19 and Flu-Elicited ARDS Using Lomecel-B (RECOVER) (clinicaltrials.gov) - Sep 30, 2021
P1, N=70, Recruiting, Sponsor: Longeveron Inc.
Trial completion date: Aug 2021 --> Dec 2021 Trial primary completion date: Aug 2021 --> Aug 2023
- | Lomecel-B (laromestrocel) / Longeveron
Trial completion date: Lomecel-B Delivered During Stage II Surgery for Hypoplastic Left Heart Syndrome (ELPIS) (clinicaltrials.gov) - Aug 18, 2021
P1/2, N=30, Active, not recruiting, Sponsor: Longeveron Inc.
Trial primary completion date: Aug 2021 --> Aug 2023 Trial completion date: Apr 2021 --> Aug 2021
- | Lomecel-B (laromestrocel) / Longeveron
Trial completion date: Lomecel-B Infusion Versus Placebo in Patients With Alzheimer's Disease (clinicaltrials.gov) - Aug 18, 2021
P1, N=33, Active, not recruiting, Sponsor: Longeveron Inc.
Trial completion date: Apr 2021 --> Aug 2021 Trial completion date: Mar 2021 --> Aug 2021
- || Lomecel-B (laromestrocel) / Longeveron
Enrollment closed: HERA: Lomecel-B on Vaccine-Specific Antibody- Response in Subjects With Aging Frailty (clinicaltrials.gov) - Aug 16, 2021
P1/2, N=83, Active, not recruiting, Sponsor: Longeveron Inc.
Trial completion date: Mar 2021 --> Aug 2021 Recruiting --> Active, not recruiting
- Lomecel-B (Longeveron mesenchymal stem cells) / Longeveron
[VIRTUAL] Safety and Efficacy of Lomecel-B in Patients with Mild Alzheimer’s Disease: Results of a Double-Blinded, Randomized, Placebo-Controlled Phase 1 Clinical Trial () - Aug 2, 2021 - Abstract #AAIC2021AAIC_1891;
P1
These hypothesis-generating results also revealed potentially important biomarkers which are consistent with multiple MOAs of Lomecel-B. Ongoing investigation of Lomecel-B for AD in larger clinical trials powered for clinical efficacy is warranted.
- Lomecel-B (Longeveron mesenchymal stem cells) / Longeveron
Safety and Efficacy of Lomecel-B in Patients with Mild Alzheimer’s Disease: Results of a Double-Blinded, Randomized, Placebo-Controlled Phase 1 Clinical Trial (Convention Ctr - Exhibit Hall F) - Aug 2, 2021 - Abstract #AAIC2021AAIC_1842;
P1
These hypothesis-generating results also revealed potentially important biomarkers which are consistent with multiple MOAs of Lomecel-B. Ongoing investigation of Lomecel-B for AD in larger clinical trials powered for clinical efficacy is warranted.
- | Lomecel-B (laromestrocel) / Longeveron
New P2b trial: ELPISII: Evaluation of Lomecel-B (clinicaltrials.gov) - Jun 14, 2021
P2b, N=38, Recruiting, Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
- | Lomecel-B (laromestrocel) / Longeveron
Trial completion date: Lomecel-B Infusion Versus Placebo in Patients With Alzheimer's Disease (clinicaltrials.gov) - Feb 18, 2021
P1, N=33, Active, not recruiting, Sponsor: Longeveron LLC
Ongoing investigation of Lomecel-B for AD in larger clinical trials powered for clinical efficacy is warranted. Trial completion date: Sep 2020 --> Mar 2021
- | Lomecel-B (laromestrocel) / Longeveron
Trial completion date, Trial primary completion date: Safety and Efficacy Trial Using Allogeneic Human Mesenchymal Stem Cells: The SIRONA Trial (clinicaltrials.gov) - Feb 18, 2021
P2, N=40, Not yet recruiting, Sponsor: Longeveron LLC
Trial completion date: Sep 2020 --> Mar 2021 Trial completion date: Jun 2022 --> Dec 2022 | Trial primary completion date: Dec 2021 --> Dec 2022
- ||| Lomecel-B (laromestrocel) / Longeveron
New P1 trial: Regenerative Medicine for COVID-19 and Flu-Elicited ARDS Using Lomecel-B (RECOVER) (clinicaltrials.gov) - Nov 15, 2020
P1, N=70, Recruiting, Sponsor: Longeveron LLC
- bone marrow-derived allogeneic stem cells (hMSCs) / University of Miami
[VIRTUAL] Clinical Evaluation of Allogeneic Mesenchymal Stem Cells for Alzheimer's Disease () - Aug 2, 2020 - Abstract #AAIC2020AAIC_3348;
P1
The results support the conclusion that LMSCs are safe in AD patients, and that advancing to higher phase clinical studies is warranted. We thank the Alzheimers Association for supporting this research through the Part the Cloud Challenge on Neuroinflammation grant awards #PTC C-16-422443 and PTC-CS-19-623225.
- || Lomecel-B (laromestrocel) / Longeveron
Trial completion date, Trial primary completion date: HERA: Lomecel-B on Vaccine-Specific Antibody- Response in Subjects With Aging Frailty (clinicaltrials.gov) - Mar 13, 2020
P1/2, N=83, Recruiting, Sponsor: Longeveron LLC
We thank the Alzheimers Association for supporting this research through the Part the Cloud Challenge on Neuroinflammation grant awards #PTC C-16-422443 and PTC-CS-19-623225. Trial completion date: Mar 2021 --> Aug 2021 | Trial primary completion date: Jan 2021 --> Apr 2021
- || Lomecel-B (laromestrocel) / Longeveron
Enrollment closed, Trial completion date, Trial primary completion date: Phase IIb Trial to Evaluate Longeveron Mesenchymal Stem Cells to Treat Aging Frailty (clinicaltrials.gov) - Mar 13, 2020
P2b, N=150, Active, not recruiting, Sponsor: Longeveron LLC
Trial completion date: Mar 2021 --> Aug 2021 | Trial primary completion date: Jan 2021 --> Apr 2021 Recruiting --> Active, not recruiting | Trial completion date: Sep 2020 --> Jul 2021 | Trial primary completion date: Jun 2020 --> Apr 2021
- | Lomecel-B (laromestrocel) / Longeveron
Trial completion date: Safety and Efficacy Trial Using Allogeneic Human Mesenchymal Stem Cells: The SIRONA Trial (clinicaltrials.gov) - Feb 23, 2020
P2, N=40, Not yet recruiting, Sponsor: Longeveron LLC
Recruiting --> Active, not recruiting | Trial completion date: Sep 2020 --> Jul 2021 | Trial primary completion date: Jun 2020 --> Apr 2021 Trial completion date: Dec 2021 --> Jun 2022
- | Lomecel-B (laromestrocel) / Longeveron
Trial completion date, Trial primary completion date: Safety and Efficacy Trial Using Allogeneic Human Mesenchymal Stem Cells: The SIRONA Trial (clinicaltrials.gov) - Nov 15, 2019
P2, N=40, Not yet recruiting, Sponsor: Longeveron LLC
Trial completion date: Dec 2021 --> Jun 2022 Trial completion date: Dec 2020 --> Dec 2021 | Trial primary completion date: Oct 2020 --> Oct 2021
- | Lomecel-B (laromestrocel) / Longeveron
Enrollment closed, Trial completion date: Lomecel-B Delivered During Stage II Surgery for Hypoplastic Left Heart Syndrome (ELPIS) (clinicaltrials.gov) - Nov 14, 2019
P1/2, N=30, Active, not recruiting, Sponsor: Longeveron LLC
Trial completion date: Dec 2020 --> Dec 2021 | Trial primary completion date: Oct 2020 --> Oct 2021 Recruiting --> Active, not recruiting | Trial completion date: Feb 2022 --> Mar 2021
- || Lomecel-B (laromestrocel) / Longeveron
Trial completion date, Trial primary completion date: HERA: Lomecel-B on Vaccine-Specific Antibody- Response in Subjects With Aging Frailty (clinicaltrials.gov) - Nov 14, 2019
P1/2, N=83, Recruiting, Sponsor: Longeveron LLC
Recruiting --> Active, not recruiting | Trial completion date: Feb 2022 --> Mar 2021 Trial completion date: Dec 2019 --> Mar 2021 | Trial primary completion date: Jun 2019 --> Jan 2021