Have there been serious adverse events or deaths linked to Memoblast in clinical trials or postmarketing reports?

1. “Memoblast” not found — names matter in drug safety

Every factual record in the supplied material refers to Mesoblast’s products under names such as remestemcel‑L (Ryoncil™/Ryoncil®) and rexlemestrocel‑L (Revascor®); none of the indexed documents mention a product called “Memoblast,” so any safety signal tied to that exact name cannot be verified from these sources (not found in current reporting). Misnaming a drug can conflate distinct safety data; therefore verify the correct product name before drawing conclusions from regulatory or trial reports (not found in current reporting).

2. Clinical‑trial safety signals: serious events recorded for Mesoblast cell therapies

Peer and press reporting of Mesoblast’s clinical programs documents serious adverse events during trials. The FDA and clinical commentators have noted infections and other serious reactions in remestemcel‑L trials, and Mesoblast’s public communications list common and serious adverse events consistent with trial reports (infections, fever, hemorrhage, edema, abdominal pain, hypertension) ^{[1] [2]}. These items are reported as observed adverse reactions in clinical settings rather than asserted single‑cause attributions by regulators in the provided excerpts ^{[1] [2]}.

3. Regulatory record shows scrutiny and at least one rejection/CRL that referenced safety and data questions

The FDA has previously issued a Complete Response Letter (CRL) for Mesoblast’s allogeneic MSC therapy, and Reuters and CGT Live reporting recount a U.S. regulator rejection that materially affected the company; the CRL and subsequent dialogues with FDA indicate the agency questioned aspects of the application — a pattern that reflects safety and evidence concerns commonly raised during review ^{[2] [4]}. Subsequent acceptance of a BLA and approvals for remestemcel‑L in a pediatric indication are also part of the record, showing regulatory judgment can evolve with additional data ^{[5] [3]}.

4. Post‑approval and commercialization: adverse reactions listed, not large‑scale mortality claims in these sources

After regulatory action, summaries of product safety in press and trade outlets list common and serious adverse reactions observed in trials; CGT Live states the FDA noted infections and the other reactions as the most common adverse reactions in the remestemcel‑L trial dataset ^[1]. The documents in your packet do not report a postmarketing surveillance finding conclusively linking the product to widespread deaths; they instead report typical serious adverse events that often occur in the high‑risk populations treated in these studies ^{[1] [3]}.

5. Clinical context and risk populations — why adverse events are expected and must be interpreted cautiously

Mesoblast’s MSC therapies have been tested in severely ill, often immunocompromised patients (pediatric steroid‑refractory acute GvHD; ischemic HFrEF cohorts), populations already at elevated risk for infection, bleeding and organ‑system complications. Trial and regulatory documents thus separate events “seen after treatment” from events conclusively caused by a cell product; available sources emphasize observed adverse reactions without attributing every serious outcome solely to the therapy ^{[1] [6]}.

6. What’s missing in the supplied record — limitations you should note

The assembled sources do not contain a line‑by‑line causality adjudication of deaths, nor do they present an exhaustive postmarketing adverse event database (e.g., FDA MedWatch aggregate reports) for these products in the content provided. If you need definitive counts of serious adverse events or deaths, or MedWatch/FAERS summaries, those are not in the current materials — you would need explicit postmarketing surveillance data or full FDA review documents not supplied here (not found in current reporting).

7. Bottom line and next steps for verification

From the provided reporting: Mesoblast’s cell therapies have documented serious adverse events in trials (notably infections and haemorrhagic and cardiorespiratory events) and have been the subject of FDA scrutiny including a CRL and later regulatory actions ^{[1] [2] [3]}. No source here mentions a product named “Memoblast.” For a definitive, up‑to‑date tally of deaths or causally linked serious adverse events, consult FDA approval documents, the product’s prescribing information, and MedWatch/FAERS datasets — materials not included in this search set (not found in current reporting).