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Kidney Failure, ChronicPhase 1TOL-1NCT02560220

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

A Phase 1 study testing Mitomycin C-induced peripheral blood mononuclear cells (MICs) in people with Kidney Failure, Chronic, run by Heidelberg University at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Kidney Failure, Chronic
What is being tested?
Mitomycin C-induced peripheral blood mononuclear cells (MICs)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteGermany
Study dates
5 Aug 2015to 18 Apr 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • Negative CDC and ELISA crossmatch
  • Immunosuppression with cyclosporin A, EC-MPS and methylprednisolone
  • Informed consent
  • Adequate contraception (women with child bearing potential)

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University of Heidelberg

    Heidelberg, Baden-Wurttemberg, 69120

Other trials in Germany

About this study

Official title: A Single-arm Phase-I Trial for the Determination of Safety and Feasibility of the Intravenous Administration of Mitomycin C-treated Donor Peripheral Blood Mononuclear Cells (MICs) for Individualized Immunosuppression in Living Donor Kidney Transplant Recipients (TOL-1 Study)

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.

Being tested
Mitomycin C-induced peripheral blood mononuclear cells (MICs)
Medical subject headings
Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

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

Study groups in NCT02560220
Study groupRoleWhat they receive
Intervention armExperimentalPatients receive MIC cell therapy together with standard immunosuppressive therapy
Receives: Biological: Mitomycin C-induced peripheral blood mononuclear cells (MICs)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 30 days

Secondary outcomes (10)

  1. Cumulative incidence of infection

    Measured: 30 days

  2. Cumulative incidence of CMV reactivation

    Measured: 30 days

  3. Number of patients with PTLD

    Measured: 30 days

  4. Number of patients with delayed graft function

    Measured: 7 days

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

    Measured: day -1 before transplantation

  6. Number of patients with DSA

    Measured: day -1 before transplantation and day 7 and 30 after transplantation

  7. Incidence of biopsy-proven cellular rejection

    Measured: 30 days

  8. Incidence of biopsy-proven antibody-mediated rejection

    Measured: 30 days

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

    Measured: 30 days

  10. Patient and graft survival

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2015 (estimated)
  2. Study start5 Aug 2015
  3. Primary completion18 Apr 2017
  4. Study completion18 Apr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02560220
Sponsor's protocol ID
TOL-1
Acronym
TOL-1
Status last verified
Jul 2018
First submitted
6 Aug 2015
Last updated
26 Jul 2018
Results posted
No
Data monitoring committee
Yes

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

  • 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.

    PubMed 37483623

  • 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.

    PubMed 36137752

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Mitomycin C-induced peripheral blood mononuclear cells (MICs) in people with Kidney Failure, Chronic, run by Heidelberg University at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary outcome measure is the frequency of adverse events after intravenous administration of MICs within 30 days after transplantation. (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02560220, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2018.

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