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Effectiveness and Safety of MMSCs for Enhancing Hematopoietic Recovery and Prophylaxis of Neutropenic Enterocolitis

NCT02145923 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2015-06-10

No results posted yet for this study

Summary

Subjects will undergo peripheral blood stem cell mobilisation and collection with subsequent high-dose chemotherapy. After finalization of high-dose chemotherapy subjects will receive bone marrow derived allogeneic multipotent mesenchymal stromal cells intravenous infusion two hours prior to autologous peripheral blood cells infusion. This is a single arm study with no control. All patients receive cell therapy.

Conditions

  • Neutropenic Enterocolitis
  • Myeloablative Chemotherapy Induced Bone Marrow Aplasia

Interventions

PROCEDURE

Peripheral blood stem cell mobilisation and collection

DRUG

High-dose chemotherapy

High-dose chemotherapy will be performed according to protocols ICE and BEAM (standard scheme)

DRUG

Bone marrow derived allogeneic MMSCs infusion

PROCEDURE

Autologous peripheral blood stem cells infusion

Sponsors & Collaborators

  • Burnasyan Federal Medical Biophysical Center

    lead OTHER_GOV

Principal Investigators

  • Zaryi Simavonyan, MD · Burnasyan Federal Medical Biophysical Center

  • Ilya I Eremin, MD, PhD · Burnasyan Federal Medical Biophysical Center

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2016-06-30
Completion
2016-12-31

Countries

  • Russia

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 NCT02145923 on ClinicalTrials.gov