Drugs / Stem Cells
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | advanced heart failure | 2026-07-01 | “Received a Biologics License Application (BLA) filing number from FDA and requested a modular review of its BLA for rexlemestrocel-L” mesoblast.com ↗ |
Trials 18
News releases announcing trial results or a regulatory action · 13
| Date | Issuer | Release |
|---|---|---|
| 2026-04-09 | Galderma R&D | Results Interim data from two ongoing investigator-initiated trials highlight the role of Sculptra® and Restylane® in addressing aesthetic changes associated with weight loss medications and menopause galderma.com ↗
Interim results demonstrated a statistically significant, four‑fold reduction in adipose‑derived stem cells (ADSCs), the regenerative cell population responsible for maintaining healthy fat tissue, when compared to those who were not taking prescription weight loss medication. |
| 2025-12-01 | Longeveron Inc. | Results Longeveron New MRI Biomarker Data Linking Neuroinflammation to Clinical Outcomes in Patients with Mild Alzheimer’s Disease Presented at the Clinical Trials on Alzheimer’s Disease Conference (CTAD 2025) longeveron.com ↗
Reduction in hippocampal neuroinflammation, measured using MRI assessed free water, correlated strongly with preservation of hippocampal volume and with clinical outcomes |
| 2025-03-11 | Longeveron Inc. | Results Longeveron® Announces Nature Medicine Publication of Results of Phase 2a Clinical Trial Evaluating Laromestrocel (Lomecel-B™) in Alzheimer’s Disease longeveron.com ↗
Phase 2a results demonstrated laromestrocel (Lomecel-B™) improved cognitive function, quality of life, and brain volume in the treatment of mild Alzheimer’s disease |
| 2023-12-18 | Personalized Stem Cells, Inc. | Results PSC Knee Osteoarthritis Stem Cell Research Results personalizedstemcells.com ↗
Personalized Stem Cells (PSC) has completed the first ever FDA-approved clinical trial of GMP lab manufactured ASCs for patients with knee osteoarthritis. |
| 2020-06-01 | Longeveron Inc. | Regulatory Longeveron Announces Japanese Approval of Clinical Trial for Treatment of Aging Frailty With Longeveron’s Stem Cells longeveron.com ↗ |
| 2019-02-19 | Longeveron Inc. | Results Longeveron LLC will discuss the company's latest clinical research of its stem cell treatments for Aging Frailty at the International Conference on Frailty & Sarcopenia Research, to be held February 20-22 at the Eden Roc Hotel on Miami Beach longeveron.com ↗
Trial participants, with an average age of 76, showed marked improvement in physical performance, lung function and reduction of inflammation, all significant biomarkers of Frailty. |
| 2018-01-23 | Longeveron Inc. | Results Longeveron Shares Promising State of Regenerative Medicine Research with Experts at the FDA, NIH and Other Leading Organizations at National Conference longeveron.com ↗
A single injection of the allogeneic mesenchymal stem cells, in fact, was associated with significant gains in functional capacity in both Phase I and Phase II studies Longeveron published in The Journals of Gerontology in 2017. |
| 2017-10-23 | Longeveron Inc. | Results University Of Miami Miller School of Medicine: Stem Cell Studies Build Momentum toward Therapy for Age-Associated Frailty longeveron.com ↗
Now Phase II randomized, placebo-controlled trial findings have verified their initial study, boosting the potential for this stem cell therapy to reverse or forestall the symptoms of frailty. |
| 2017-10-20 | Longeveron Inc. | Results Miami Herald: Stem cell infusions improved health in frail elderly, UM researchers say longeveron.com ↗
The first phase of Hare’s study, which involved 15 people, showed that stem cell infusions were safe for patients. |
| 2017-10-17 | Longeveron Inc. | Results Longeveron Pioneering Development of Stem Cell Therapies for Aging Frailty longeveron.com ↗
Participants showed marked improvement in physical performance, lung function and inflammation biomarkers, all major aspects of frailty, with no serious adverse events attributable to the product. |
| 2017-05-15 | Longeveron Inc. | Results Longeveron Announces Publication of Phase 1 Safety and Efficacy Trial Results for Allogeneic Stem Cell Treatment in Frailty Patients longeveron.com ↗
Longeveron LLC, a leading regenerative medicine company developing innovative therapies for age-related diseases, announced the publication of Phase 1 safety, tolerability and efficacy data of its proprietary allogeneic mesenchymal stem cell (MSC) product in patients with Aging Frailty. |
| 2017-05-10 | Longeveron Inc. | Results Longeveron Begins Enrollment of Second Cohort of Phase 1 Trial of Allogeneic Mesenchymal Stem Cells to Treat Alzheimer’s Disease Patients longeveron.com ↗
The first five patients in our program have so far shown that the use of LMSCs in Alzheimer’s disease is safe. |
| 2015-06-09 | Stemedica Cell Technologies, Inc. | Regulatory FDA Grants IND Approval for Phase IIa Clinical Trial Using Stemedica’s ITMSC Therapy to Treat Alzheimer’s Disease stemedica.com ↗ |
All press releases naming this drug 13 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 18 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | stem cells | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01626625 ↗ |
| Action | Activate | “enhance and activate the spermatogonial stem cells” NCT02025270 ↗ |
| Modality | Cell therapy | “Stem cell infusion on day 0.” NCT00683046 ↗ |
| Route | Intravenous | “The infusion of blood stem cells is given through the catheter the day after the last dose of chemotherapy.” NCT01702961 ↗ |