ORBCEL-M

Developed for: diabetic kidney disease · ulcer of lower limbs
Investigated by: Leiden University Medical Center · Belfast Health and Social Care Trust · Istituto Di Ricerche Farmacologiche Mario Negri · Mario Negri Institute for Pharmacological Research · NHS Blood and Transplant · National University of Ireland, Galway, Ireland
+3 more
· Papa Giovanni XXIII Hospital · Steno Diabetes Center Copenhagen · University Hospital Birmingham NHS Foundation Trust

today NCT03509870 · Ph 1 NCT02585622 · Ph 1/2

2018201920202021202220232024202520262027

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 11 trial
Phase 1	NCT03509870	Jun 2018 → Apr 2020	ulcer of lower limbs	Steno Diabetes Center Copenhagen	Terminated	No outcome recorded Stop: Enrollment
Phase 1/21 trial
Phase 1/2	NCT02585622	Dec 2017 → Nov 2022	diabetic kidney disease	Mario Negri Institute for Pharmacological Research	Terminated	No outcome recorded Stop: Enrollment

Every value below carries the sentence it was read from. 3 sources stand behind the page.

Field	Value	Cited text
Known as	ORBCEL-M	“To examine the safety of topical application of a single dose of allogeneic bone marrow derived mesenchymal stromal cells (REDDSTAR ORBCEL-M) seeded in a collagen scaffold to...” NCT03509870 ↗ 1 “Safety and Preliminary Efficacy of Mesenchymal Stromal Cell (ORBCEL-M) Therapy in Diabetic Kidney Disease: A Randomized Clinical Trial (NEPHSTROM).” PMID 37560967 ↗ Aug 2023
Modality	Cell therapy	“allogeneic bone marrow-derived Mesenchymal Stromal Cell (MSC) therapy (ORBCEL-M)” NCT02585622 ↗
Route	Intravenous	“receive intravenous infusion of ORBCEL-M” PMID 37560967 ↗ Aug 2023