NCT00734396

Brief Summary

The purpose of the study is to test the safety and feasibility of autologous mesenchymal stem cell therapy in HLA-DR mismatched patients with subclinical rejection and or an increase in IF?TA in the renal biopsy 4 weeks or 6 months after renal transplantation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2009

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 14, 2008

Completed
6 months until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

January 7, 2013

Status Verified

January 1, 2013

Enrollment Period

3.1 years

First QC Date

August 13, 2008

Last Update Submit

January 4, 2013

Conditions

Organ Transplantation

Keywords

Mesenchymal stem cellsAllograft rejectionSubclinical rejection

Outcome Measures

Primary Outcomes (1)

  • Primary 1 Safety: rate of (serious) adverse events in the study population 2 Feasibility: determination of the number of expanded MSCs in relation to the amount of BM collected, number of passages required and time to reach study target doses

    2 years

Secondary Outcomes (1)

  • Secondary endpoints: 1 Presence of late acute rejection (in the 6 month biopsy compared with the 4 week biopsy). 2 Sirius red staining for renal cortical matrix accumulation. 3 Immunologic response before and after MSC infusion.

    2 years

Interventions

Mesenchymal stem cell infusionPROCEDURE

MSC infusion: two doses of 1-2x106 MSCs per kilogram body weight, intravenously, 7 days apart.

Also known as: Bone marrow derived mesenchymal stem cells.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject is willing to participate in the study and has signed the informed consent.
  • Recipients of a first kidney graft from a living HLA-DR mismatched donor (2 HLA-DR mismatches).
  • Subjects included in the study must have kidney biopsy proven SCR 4 weeks after transplantation.
  • Patients must be on triple immunosuppressive therapy of prednisone, CsA or tacrolimus and MMF according to current protocol.
  • Panel Reactive Antibodies (PRA) ≤ 5%.
  • Patients must be able to adhere to the study visit schedule and protocol requirements.
  • If female and of child-bearing age, subject must be non-pregnant, non-breastfeeding, and use adequate contraception.
  • Patients must be able to give informed consent and the consent must be obtained prior to any study procedure.

You may not qualify if:

  • Double organ transplant recipient.
  • Acute clinical rejection after transplantation.
  • Patients with evidence of active infection or abcesses before MSC infusion.
  • Patients suffering from hepatic failure.
  • Patients suffering from an active autoimmune disease.
  • Patients who have had a previous BM transplant.
  • A psychiatric, addictive or any disorder that compromises ability to give truly informed consent for participation in this study.
  • Use of any investigational drug after transplantation.
  • Subjects who currently have an active opportunistic infection (e.g., herpes zoster \[shingles\], cytomegalovirus (CMV), Pneumocystis carinii (PCP), aspergillosis, histoplasmosis, or mycobacteria other than TB) after transplantation.
  • Known recent substance abuse (drug or alcohol).
  • Contraindications to undergo a BM biopsy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leiden Universitary Medical Center

Leiden, 2333 ZA, Netherlands

Location

Related Publications (1)

  • Reinders ME, de Fijter JW, Roelofs H, Bajema IM, de Vries DK, Schaapherder AF, Claas FH, van Miert PP, Roelen DL, van Kooten C, Fibbe WE, Rabelink TJ. Autologous bone marrow-derived mesenchymal stromal cells for the treatment of allograft rejection after renal transplantation: results of a phase I study. Stem Cells Transl Med. 2013 Feb;2(2):107-11. doi: 10.5966/sctm.2012-0114. Epub 2013 Jan 24.

    PMID: 23349326DERIVED

Study Officials

  • Marlies Reinders, MD, PhD

    LUMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

August 13, 2008

First Posted

August 14, 2008

Study Start

February 1, 2009

Primary Completion

March 1, 2012

Study Completion

December 1, 2012

Last Updated

January 7, 2013

Record last verified: 2013-01

Locations

NL(1)