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Umbilical Cord Derived Mesenchymal Stromal Cells For The Treatment of Severe Steroid-resistant Graft Versus Host Disease

NCT02032446 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2019-01-18

No results posted yet for this study

Summary

MESENCHYMAL STROMAL CELLS (MSC) have shown promising albeit not always consistent therapeutic effects in the treatment of severe steroid-resistant acute Graf versus Host Disease. Remarkably, in all reported clinical studies the toxicity of Mesenchymal stromal cells administration has been found consistently negligible. The investigators believe that Umbilical Cord (UC) derived Mesenchymal stromal cells may represent a stronger immunosuppressive tool for such clinical emergency and no data suggest any change in the safety profile of these cells. For this reason, and in the best interest of the patient, the investigators plan to test the safety and activity of Umbilical Cord Mesenchymal stromal cells when given sequentially to another partially effective treatment of steroid resistant acute graf versus host disease such as Pentostatin.

Conditions

Interventions

BIOLOGICAL

UMBILICAL CORD DERIVED MESENCHYMAL STROMAL CELLS (UC-MSC)

pentostatin, dose 1 mg/m2 § MSC doses: 1. 3 patients → 3 infusions of 1x106 cells /kg 2. 3 patients → 3 infusions of 2x106 cells /kg 3. 3 patients → 3 infusions of 3x106 cells /kg

Sponsors & Collaborators

  • Associazione Italiana per la Ricerca sul Cancro

    collaborator OTHER

  • A.O. Ospedale Papa Giovanni XXIII

    lead OTHER

Principal Investigators

  • Alessandro Rambaldi, MD · A.O. Ospedale Papa Giovanni XXIII

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2016-09-30
Completion
2019-09-30

Countries

  • Italy

Study Locations

More Related Trials

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 NCT02032446 on ClinicalTrials.gov