ORBCEL-M (Bone marrow-derived mesenchymal stromal cells) / Orbsen - LARVOL DELTA

NEPHSTROM for Diabetic Kidney Disease (clinicaltrials.gov) - P1/2 | N=29 | Terminated | Sponsor: Mario Negri Institute for Pharmacological Research | N=48 ➔ 29 | Active, not recruiting ➔ Terminated; IMP NEPHSTROM ORBECEL-M is expired and additional extension is not feasible. Low recruitment rate at Birmingham center.

Enrollment change • Stroma • Trial termination • Diabetic Nephropathy • Nephrology • Renal Disease

NEPHSTROM for Diabetic Kidney Disease (clinicaltrials.gov) - P1/2 | N=48 | Active, not recruiting | Sponsor: Mario Negri Institute for Pharmacological Research | Trial completion date: Dec 2023 ➔ Mar 2024

Stroma • Trial completion date • Diabetic Nephropathy • Nephrology • Renal Disease

Safety and Preliminary Efficacy of Mesenchymal Stromal Cell (ORBCEL-M Cell) Therapy in Diabetic Kidney Disease: A Randomized Clinical Trial (NEPHSTROM). (PubMed, J Am Soc Nephrol) - "Findings indicate safety and tolerability of intravenous ORBCEL-M cell therapy in the trial's lowest-dose cohort. The rate of decline in eGFR (but not mGFR) over 18 months was significantly lower among those receiving cell therapy compared with placebo. Further studies will be needed to determine the therapy's effect on CKD progression."

Clinical • Journal • Stroma • Diabetes • Diabetic Nephropathy • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus • SDC2

Safety and Preliminary Efficacy Results of a Novel Mesenchymal Stromal Cell Therapy in Diabetic Kidney Disease: The Multicenter, Randomized, Placebo-Controlled, Phase-1b/2a NEPHSTROM Clinical Trial (KIDNEY WEEK 2022) - "Values are median [IQR]. *Wilcoxon rank sum ORBCEL-M vs Placebo"

Clinical • P1/2 data • Diabetes • Diabetic Nephropathy • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus • SDC2

NEPHSTROM for Diabetic Kidney Disease (clinicaltrials.gov) - P1/2 | N=48 | Active, not recruiting | Sponsor: Mario Negri Institute for Pharmacological Research | Recruiting ➔ Active, not recruiting | Trial completion date: Jul 2022 ➔ Dec 2023 | Trial primary completion date: Dec 2021 ➔ Dec 2023

Enrollment closed • Trial completion date • Trial primary completion date • Diabetic Nephropathy • Nephrology • Renal Disease • CCL2 • FGF21 • IL1B • IL6 • TNFRSF1A

NEPHSTROM for Diabetic Kidney Disease (clinicaltrials.gov) - P1/2; N=48; Recruiting; Sponsor: Mario Negri Institute for Pharmacological Research; Trial completion date: Dec 2021 ➔ Jul 2022; Trial primary completion date: Jun 2021 ➔ Dec 2021

Trial completion date • Trial primary completion date • Diabetic Nephropathy • Nephrology • Renal Disease • CCL2 • FGF21 • IL1B • IL6

NEPHSTROM for Diabetic Kidney Disease (clinicaltrials.gov) - P1/2; N=48; Not yet recruiting; Sponsor: Mario Negri Institute for Pharmacological Research; Initiation date: Jan 2017 ➔ Apr 2017

Trial initiation date • Diabetic Nephropathy • Nephrology • Renal Disease • CCL2 • FGF21 • IL1B • IL6

NEPHSTROM for Diabetic Kidney Disease (clinicaltrials.gov) - P1/2; N=48; Not yet recruiting; Sponsor: Mario Negri Institute for Pharmacological Research; Initiation date: May 2016 ➔ Jan 2017; Trial primary completion date: Dec 2018 ➔ May 2019

Trial initiation date • Trial primary completion date • Diabetic Nephropathy • Nephrology • Renal Disease • CCL2 • FGF21 • IL1B • IL6

NEPHSTROM for Diabetic Kidney Disease (clinicaltrials.gov) - P1/2; N=48; Not yet recruiting; Sponsor: Mario Negri Institute for Pharmacological Research; Trial primary completion date: May 2019 ➔ Sep 2019

Trial primary completion date • Diabetic Nephropathy • Nephrology • Renal Disease • CCL2 • FGF21 • IL1B • IL6

NEPHSTROM for Diabetic Kidney Disease (clinicaltrials.gov) - P1/2; N=48; Not yet recruiting; Sponsor: Mario Negri Institute for Pharmacological Research

New P1/2 trial • Diabetic Nephropathy • Nephrology • Renal Disease • CCL2 • FGF21 • IL1B • IL6

NEPHSTROM for Diabetic Kidney Disease (clinicaltrials.gov) - P1/2; N=48; Not yet recruiting; Sponsor: Mario Negri Institute for Pharmacological Research; Initiation date: Apr 2017 ➔ Jul 2017; Trial primary completion date: Sep 2019 ➔ Apr 2019

Trial initiation date • Trial primary completion date • Diabetic Nephropathy • Nephrology • Renal Disease • CCL2 • FGF21 • IL1B • IL6

NEPHSTROM for Diabetic Kidney Disease (clinicaltrials.gov) - P1/2; N=48; Recruiting; Sponsor: Mario Negri Institute for Pharmacological Research; Not yet recruiting ➔ Recruiting; Trial primary completion date: Apr 2019 ➔ Jun 2020

Enrollment open • Trial primary completion date • Diabetic Nephropathy • Nephrology • CCL2 • FGF21 • IL1B • IL6

NEPHSTROM for Diabetic Kidney Disease (clinicaltrials.gov) - P1/2; N=48; Recruiting; Sponsor: Mario Negri Institute for Pharmacological Research; Trial completion date: Dec 2020 ➔ Dec 2021; Trial primary completion date: Jun 2020 ➔ Jun 2021

Trial completion date • Trial primary completion date • Diabetic Nephropathy • Nephrology • Renal Disease • CCL2 • FGF21 • IL1B • IL6

NEPHSTROM for Diabetic Kidney Disease (clinicaltrials.gov) - P1/2; N=48; Not yet recruiting; Sponsor: Mario Negri Institute for Pharmacological Research; Initiation date: Jul 2017 ➔ Dec 2017

Trial initiation date • Diabetic Nephropathy • Nephrology • Renal Disease • CCL2 • FGF21 • IL1B • IL6

REDDSTAR: Bone Marrow Derived Allogeneic Mesenchymal Stromal Cells to Non-healing Diabetic Foot Wounds (clinicaltrials.gov) - P1; N=2; Terminated; Sponsor: Steno Diabetes Center Copenhagen; Trial completion date: Dec 2019 ➔ Apr 2020; Recruiting ➔ Terminated; Trial primary completion date: Dec 2019 ➔ Apr 2020; study stopped because of lack of recruitment

Clinical • Trial completion date • Trial primary completion date • Trial termination