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Allogeneic Mesenchymal Stromal Cell Therapy in Renal Transplant Recipients

NCT02387151 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2019-07-02

No results posted yet for this study

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.

Conditions

  • Rejection
  • Graft Loss

Interventions

DRUG

mesenchymal stromal cells

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

Sponsors & Collaborators

  • Leiden University Medical Center

    lead OTHER

Principal Investigators

  • Marlies EJ Reinders, MD/PhD · Leiden University Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2018-11-30
Completion
2018-11-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02387151 on ClinicalTrials.gov