NCT02387151

Brief Summary

This study will test whether selected allogeneic bone marrow derived MSCs are safe by assessing the composite end point Biopsy Proven Acute Rejection (BPAR)/ graft loss at 12 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2015

Typical duration 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

Study Start

First participant enrolled

March 1, 2015

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 12, 2015

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

July 2, 2019

Status Verified

June 1, 2019

Enrollment Period

3.7 years

First QC Date

March 3, 2015

Last Update Submit

June 30, 2019

Conditions

RejectionGraft Loss

Keywords

Mesenchymal Stromal CellsRejection

Outcome Measures

Primary Outcomes (1)

  • biopsy proven acute rejection / graft loss

    12 months after transplantation

Secondary Outcomes (5)

  • Comparison of fibrosis by quantitative Sirius Red scoring

    Before MSC infusion (week 24 after transplantation) and 6 months after MSC infusion (week 52 after transplantation)

  • Serious adverse events

    12 months after transplantation

  • Renal function measured by cGFR (MDRD formula) and iohexol clearance

    week 24 after transplantation (before MSC infusion) and 52 after transplantation

  • CMV, BK infection (viremia, disease and syndrome; and subtypes of BK viremia) and other opportunistic infections

    from baseline up to 26 weeks after MSC treatment

  • Development of de novo donor specific antibodies (DSA) and immunological responses

    at baseline, week 24 after transplantation (before MSC treatment) up to week 26 after MSC treatment

Study Arms (1)

mesenchymal stromal cells

EXPERIMENTAL

allogeneic mesenchymal stromal cell infusion

Drug: mesenchymal stromal cells

Interventions

mesenchymal stromal cellsDRUG

2 doses of 1-2x10\^6 allogeneic bone marrow derives MSCs IV per/kg body weight at weeks 25 and 26 after transplantation

Also known as: MSC, bone marrow derived mesenchymal stromal cells
mesenchymal stromal cells

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject is willing to participate in the study, must be able to give informed consent and the consent must be obtained prior to any study procedure.
  • Recipients of a first kidney graft from a living-unrelated or non-HLA identical living related donor.
  • Panel Reactive Antibodies (PRA) ≤ 50%.
  • 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.

You may not qualify if:

  • Double organ transplant recipient.
  • Biopsy proven acute rejection (according to the Banff criteria) in the 4 weeks before MSC infusion.
  • Patients with evidence of active infection or abscesses (with the exception of an uncomplicated urinary tract infection) before MSC infusion.
  • Patients suffering from hepatic failure.
  • Patients suffering from an active autoimmune disease.
  • 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 an active opportunistic infection at the time of MSC infusion (e.g., herpes zoster \[shingles\], cytomegalovirus (CMV), Pneumocystis carinii (PCP), aspergillosis, histoplasmosis, or mycobacteria other than tuberculosis, BK) after transplantation.
  • Known recent substance abuse (drug or alcohol).
  • Patients who are recipients of ABO incompatible transplants.
  • Patients with severe total hypercholesterolemia (\>7.5 mmol/L) or total hypertriglyceridemia (\>5.6 mmol/L) (patients on lipid lowering treatment with controlled hyperlipidemia are acceptable).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leiden University Medical Center

Leiden, 2333 ZA, Netherlands

Location

Related Publications (1)

  • Reinders ME, Dreyer GJ, Bank JR, Roelofs H, Heidt S, Roelen DL, Zandvliet ML, Huurman VA, Fibbe WE, van Kooten C, Claas FH, Rabelink TJ, de Fijter JW. Safety of allogeneic bone marrow derived mesenchymal stromal cell therapy in renal transplant recipients: the neptune study. J Transl Med. 2015 Nov 4;13:344. doi: 10.1186/s12967-015-0700-0.

    PMID: 26537851DERIVED

MeSH Terms

Conditions

Rejection, Psychology

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Officials

  • Marlies EJ Reinders, MD/PhD

    Leiden University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 3, 2015

First Posted

March 12, 2015

Study Start

March 1, 2015

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

July 2, 2019

Record last verified: 2019-06

Locations

NL(1)