MIC Cell Therapy for Individualized Immunosuppression in Living Donor Kidney Transplant Recipients

Summary

A phase- I clinical trial to determine safety and feasibilty of intravenous administration of mitomycin C-treated donor peripheral blood mononuclear cells in patients with chronic kidney disease stage KDIGO 4 or 5 (i.e. GFR 15-30 mL/min or \< 15 mL/min) who receive a kidney transplant from a living donor.

Timeline

Start

2015-08-05

Primary completion

2017-04-18

Completion

2017-04-18

Publications

• Background Morath C, Schmitt A, Zeier M, Schmitt M, Sandra-Petrescu F, Opelz G, Terness P, Schaier M, Kleist C. Cell therapy for immunosuppression after kidney transplantation. Langenbecks Arch Surg. 2015 Jul;400(5):541-50. doi: 10.1007/s00423-015-1313-z. Epub 2015 Jun 17.
• Background Kleist C, Sandra-Petrescu F, Jiga L, Dittmar L, Mohr E, Greil J, Mier W, Becker LE, Lang P, Opelz G, Terness P. Generation of suppressive blood cells for control of allograft rejection. Clin Sci (Lond). 2015 May;128(9):593-607. doi: 10.1042/CS20140258.
• Background Dittmar L, Mohr E, Kleist C, Ehser S, Demirdizen H, Sandra-Petrescu F, Hundemer M, Opelz G, Terness P. Immunosuppressive properties of mitomycin C-incubated human myeloid blood cells (MIC) in vitro. Hum Immunol. 2015 Jul;76(7):480-7. doi: 10.1016/j.humimm.2015.06.008. Epub 2015 Jun 11.
• Background Terness P, Oelert T, Ehser S, Chuang JJ, Lahdou I, Kleist C, Velten F, Hammerling GJ, Arnold B, Opelz G. Mitomycin C-treated dendritic cells inactivate autoreactive T cells: toward the development of a tolerogenic vaccine in autoimmune diseases. Proc Natl Acad Sci U S A. 2008 Nov 25;105(47):18442-7. doi: 10.1073/pnas.0807185105. Epub 2008 Nov 18.
• Schaier M, Morath C, Wang L, Kleist C, Opelz G, Tran TH, Scherer S, Pham L, Ekpoom N, Susal C, Ponath G, Kalble F, Speer C, Benning L, Nusshag C, Mahler CF, Pego da Silva L, Sommerer C, Huckelhoven-Krauss A, Czock D, Mehrabi A, Schwab C, Waldherr R, Schnitzler P, Merle U, Schwenger V, Krautter M, Kemmner S, Fischereder M, Stangl M, Hauser IA, Kalsch AI, Kramer BK, Bohmig GA, Muller-Tidow C, Reiser J, Zeier M, Schmitt M, Terness P, Schmitt A, Daniel V. Five-year follow-up of a phase I trial of donor-derived modified immune cell infusion in kidney transplantation. Front Immunol. 2023 Jul 11;14:1089664. doi: 10.3389/fimmu.2023.1089664. eCollection 2023.
• Morath C, Schaier M, Ibrahim E, Wang L, Kleist C, Opelz G, Susal C, Ponath G, Aly M, Alvarez CM, Kalble F, Speer C, Benning L, Nusshag C, Pego da Silva L, Sommerer C, Huckelhoven-Krauss A, Czock D, Mehrabi A, Schwab C, Waldherr R, Schnitzler P, Merle U, Tran TH, Scherer S, Bohmig GA, Muller-Tidow C, Reiser J, Zeier M, Schmitt M, Terness P, Schmitt A, Daniel V. Induction of Long-Lasting Regulatory B Lymphocytes by Modified Immune Cells in Kidney Transplant Recipients. J Am Soc Nephrol. 2023 Jan 1;34(1):160-174. doi: 10.1681/ASN.2022020210. Epub 2022 Sep 22.
• Morath C, Schmitt A, Kleist C, Daniel V, Opelz G, Susal C, Ibrahim E, Kalble F, Speer C, Nusshag C, Pego da Silva L, Sommerer C, Wang L, Ni M, Huckelhoven-Krauss A, Czock D, Merle U, Mehrabi A, Sander A, Hackbusch M, Eckert C, Waldherr R, Schnitzler P, Muller-Tidow C, Hoheisel JD, Mustafa SA, Alhamdani MS, Bauer AS, Reiser J, Zeier M, Schmitt M, Schaier M, Terness P. Phase I trial of donor-derived modified immune cell infusion in kidney transplantation. J Clin Invest. 2020 May 1;130(5):2364-2376. doi: 10.1172/JCI133595.

Drugs

Indications