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Table 7 Compilation of “Histology” Potency Tests for the 31 US FDA-Approved CTPs

From: Analysis of the measurements used as potency tests for the 31 US FDA-approved cell therapy products

Product

Histology

Number (Total = 2)

Gintuit

• “Histology assay”

1

Rethymic

• “Histology-based potency test method”

1

  1. Quotes are from the FDA website (the product’s Summary Basis for Regulatory Action)