	US 12,213,998 B2
	Adipose tissue-derived stromal stem cells for use in treating refractory complex perianal fistulas in Crohn's disease
Eduardo Bravo, Madrid (ES); and Maria Pascual, Madrid (ES)
Assigned to Takeda Pharmaceutical Company Limited, Osaka (JP)
Filed by Takeda Pharmaceutical Company Limited, Osaka (JP)
Filed on Feb. 14, 2022, as Appl. No. 17/671,479.
Application 17/671,479 is a continuation of application No. 16/452,321, filed on Jun. 25, 2019, granted, now 11,273,182.
Application 16/452,321 is a continuation of application No. 15/458,509, filed on Mar. 14, 2017, granted, now 10,357,518, issued on Jul. 23, 2019.
Claims priority of application No. 1604304 (GB), filed on Mar. 14, 2016.
Prior Publication US 2022/0249574 A1, Aug. 11, 2022
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 35/35 (2015.01); A61K 35/28 (2015.01)

CPC A61K 35/35 (2013.01) [A61K 35/28 (2013.01)]

20 Claims

1. A method of treating a complex perianal fistula in a subject having Crohn's disease comprising administering a therapeutic amount of a population of expanded allogeneic adipose tissue-derived stem cells to the subject, wherein:

(i) the fistula comprises a complex fistula with 1 or 2 internal openings and/or 2 or 3 external openings;

(ii) the therapeutic amount is a fixed dose of expanded allogeneic adipose tissue-derive stem cells which is administered to the subject in a single administration, wherein a further administration is excluded, wherein each fistula tract receives at least a proportion of this dose and wherein approximately half of the dose is injected into the tissue surrounding the internal opening or openings and the other half is injected into the fistula walls along the fistula tracts; and

(iii) the fixed dose is about 120 million expanded allogeneic adipose tissue-derived stem cells.