Stem-cell treatments

Grader A: partial

Approved novel stem-cell products are few and niche: Holoclar (EU 2015), Alofisel (EU 2018, withdrawn 2024), Ryoncil (FDA Dec 2024). Real use well under 5%. HSCT was routine long before 2012, so the poster's forward-looking reading excludes it; under that reading it would be a hit.

Test: D37 health: share of relevant patients, providers or procedures using it by 2022 (hit >=5%; partial <5% real use by 2022 or 5% in 2023-2025; miss no real use by 2025); relevant: patients with the indicated conditions

• FDA approves Ryoncil, an allogeneic MSC therapy (2025): First FDA-approved MSC therapy Dec 2024
• Current Landscape of FDA Stem Cell Approvals and Trials 2023-2025 (2025): Approved stem-cell therapies remain limited to few indications

Grader B: partial

Approved regenerative stem-cell products exist (EU Holoclar, Alofisel; US Ryoncil approved Dec 2024, Omisirge, Lantidra) and are used, but in narrow indications and small numbers. Haematopoietic stem-cell transplant was routine long before 2012 and is not the poster's forward-looking reading; under that reading the claim would be an earlier hit, noted as a minority reading.

Test: D37 health: >=5% of patients in the target indications receive stem-cell therapy by 2022 = hit; real but niche approved use = partial; none by 2025 = miss.

• Approved Cellular and Gene Therapy Products (2026): Approved stem-cell products are cord-blood HPC units plus a few MSC/islet products (Ryoncil, Omisirge, Lantidra), all narrow indications.