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CompletedNCT02560220TOL-1Updated Jul 26, 2018

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

A Phase 1 interventional study of Mitomycin C-induced peripheral blood mononuclear cells (MICs) in Kidney Failure, Chronic, sponsored by Heidelberg University. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-26.

Sponsored by Heidelberg University · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
14
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Kidney Failure, Chronic
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In context

Renal Insufficiency

1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.

This study's enrollment of 14 is below the median of 43 across 1,504 interventional studies indexed under Renal Insufficiency.

Browse Renal Insufficiency studies →

Lead sponsor

Heidelberg University is the lead sponsor of 279 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Chronic kidney disease stage KDIGO 4 or 5
  • First kidney transplant from a living donor
  • Age ≥ 18 years
  • ABO compatible
  • CDC-PRA \< 20%
  • No donor-specific antibodies
  • Negative CDC and ELISA crossmatch
  • Immunosuppression with cyclosporin A, EC-MPS and methylprednisolone
  • Informed consent
  • Adequate contraception (women with child bearing potential)

Exclusion criteria

Exclusion Criteria:

  • Psychiatric disorder
  • Heart failure (NYHA III or IV)
  • Severe liver disease
  • Active hepatitis B or C or HIV infection
  • Active bacterial, fungal or viral disease
  • Malignancy or malignancy in the last 5 years before screening
  • Preexisting immunosuppression
  • Vaccination with a live vaccine in the last 3 months before screening
  • S/p splenectomy
  • Substance abuse
  • Pregnancy or lactation
  • Women: Child/pregnancy with the intended donor
  • Allergy against the investigational drug or part of it
  • Other diseases that prohibit participation in the study (in the opinion of the investigator)
  • Participation in an other interventional study
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Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
14 participants (actual)

Study arms

  • Experimental
    Intervention arm

    Patients receive MIC cell therapy together with standard immunosuppressive therapy

    Biological: Mitomycin C-induced peripheral blood mononuclear cells (MICs)

Interventions

  • BiologicalMitomycin C-induced peripheral blood mononuclear cells (MICs)

    MICs are given intravenously 2 or 7 days before kidney transplantation from a living donor

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What researchers measure

Primary outcomes

  1. The primary outcome measure is the frequency of adverse events after intravenous administration of MICs within 30 days after transplantation.

    Time frame: 30 days

Secondary outcomes

  1. Cumulative incidence of infection

    Time frame: 30 days

  2. Cumulative incidence of CMV reactivation

    Time frame: 30 days

  3. Number of patients with PTLD

    Time frame: 30 days

  4. Number of patients with delayed graft function

    Time frame: 7 days

  5. Number of patients with a pos. CDC and/or ELISA crossmatch

    Time frame: day -1 before transplantation

  6. Number of patients with DSA

    Time frame: day -1 before transplantation and day 7 and 30 after transplantation

  7. Incidence of biopsy-proven cellular rejection

    Time frame: 30 days

  8. Incidence of biopsy-proven antibody-mediated rejection

    Time frame: 30 days

  9. Number of patients with stable graft function (S-creatinine < 2mg/dL)

    Time frame: 30 days

  10. Patient and graft survival

    Time frame: 30 days

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Study locations

1 site
  • University of Heidelberg
    Heidelberg, Baden-Wuerttemberg 69120, Germany
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References and documents

Publications

  • 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. PubMed 26077202 ↗
  • 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. PubMed 25495457 ↗
  • 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. PubMed 26074415 ↗
  • 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. PubMed 19017789 ↗
  • 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. PubMed 31990685 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 26, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02560220
Lead sponsor
Heidelberg University
Collaborators
WiSP GmbH, German Federal Ministry of Economics and Technology
Responsible party
Christian Morath, M.D. (Martin Zeier, M. D., Heidelberg University) — Principal investigator
First posted
Sep 25, 2015
Start date
Aug 5, 2015
Primary completion
Apr 18, 2017
Completion
Apr 18, 2017
Last update
Jul 26, 2018

Study contacts

Martin Zeier, MD
principal investigator · Heidelberg University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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