Synthetic blood

Grader A: partial

No synthetic blood is approved in the US/EU; lab-grown RBCs reached only a first-in-human trial (RESTORE, Nov 2022, 5-10 ml). Hemopure (HBOC-201) is registered for routine use in South Africa and Russia and given under US expanded access, a niche real use far below 5% of transfusions.

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: transfusion patients

• First ever clinical trial of laboratory grown red blood cells being transfused into another person (2022-11-07): Lab-grown RBCs first given to humans in a trial, 5-10 ml doses
• New Applications of HBOC-201: A 25-Year Review of the Literature (2021): HBOC-201 approved in South Africa and Russia, not FDA-approved; US use via expanded access

Grader B: partial

No substitute is approved in the US or EU; Hemopure is approved only in South Africa and Russia and sees niche use. The first lab-grown red cells were transfused to volunteers in the RESTORE trial in Nov 2022. Real use exists only as niche approvals and a first-in-human pilot, far below 5% of transfusions.

Test: D37 health: >=5% of transfusions use a substitute by 2022 = hit; real use below 5% (pilots, niche approvals) or 5% in 2023-2025 = partial; no real use by 2025 = miss.

• First ever clinical trial of laboratory grown red blood cells being transfused into another person (2022-11-07): RESTORE trial: first two people transfused with lab-grown red cells; research stage.
• Blood substitute (Wikipedia) (2026): Fluosol was the only FDA-approved oxygen therapeutic (1989, withdrawn 1994); Hemopure approved only in South Africa and Russia; none approved in the US.