Mesenchymal Stromal Cell Therapy in Renal Recipients

NCT02057965 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2020-09-17

No results posted yet for this study

Summary

This study will test the hypothesis that MSCs in combination with Everolimus facilitate Tacrolimus withdrawal, reduce fibrosis and decrease the incidence of opportunistic infections compared to standard tacrolimus dose.

Conditions

Interventions

DRUG

Mesenchymal Stromal Cells

Two doses of autologous bone marrow (BM) derived MSCs IV, 7 days apart, 6 and 7 weeks after transplantation. Doses of MSCs will be 1-2x10\^6 million MSCs per/kg body weight

Sponsors & Collaborators

  • Leiden University Medical Center

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2020-01-31
Completion
2022-01-31

Countries

  • Netherlands

Study Locations

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Entities

Diseases

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 NCT02057965 on ClinicalTrials.gov