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

June 9, 2015 updated by: Zarui Simavonyan, Burnasyan Federal Medical Biophysical Center

Effectiveness and Safety of Intravenous Infusion of Bone Marrow Derived Allogeneic Multipotent Mesenchymal Stromal Cells for Enhancing Hematopoietic Recovery and Prophylaxis of Neutropenic Enterocolitis in Hematological Patients With Aplasia After High-dose Chemotherapy.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients with verified diagnosis Hodgkin's lymphoma or non-Hodgkin's lymphoma will undergo peripheral blood stem cell mobilisation and collection (chemotherapy + G-CSF or G-CSF+Plerixafor).

After that high-dose chemotherapy will be performed according to protocols ICE and BEAM (standard scheme).

Patient will receive bone marrow derived allogeneic multipotent mesenchymal stromal cells infusion 48 hours after last administration of cytotoxic agent . Number of cells calculated according to patient's body weight (1,5-2,0 mln of cells/kg), time of infusion - 30 minutes. Two hours later patient will receive autologous peripheral blood cells infusion.

Study Type

Interventional

Enrollment (Anticipated)

16

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 123182
        • State Research Center Burnasyan Federal Medical Biophysical Center FMBA of Russia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient suffers from Hodgkin's lymphoma, non-Hodgkin's lymphoma with complete or partial remission.
  • Patient is candidate to high-dose chemotherapy with subsequent autologous hematopoietic stem cell transplantation.
  • Absence of infection, cardiovascular, respiratory, renal and hepatic dysfunctions, focal neurological symptoms.
  • Karnofsky score at least 70.
  • Patient successfully undergone mobilization of peripheral blood stem cells.
  • Patient is familiar with Participant information sheet.
  • Patient signed informed consent form.

Non-inclusion Criteria:

  • Severe chronic comorbidity with symptoms of organ or system failure.
  • Significant abnormalities in laboratory tests.
  • Participation in other clinical trials (or intake of study drugs) within prior 3 months.
  • Conditions restricting commitment to participating in the trial (dementia, neuropsychiatric disorders, drug and alcohol abuse)
  • Patients with malignant solid tumors.
  • Patients with medical history of heterotopic ossification.

Exclusion Criteria:

  • Progression or relapse of lymphoma during therapy.
  • Confirmed syphilis, HIV, hepatitis B or C infection
  • Absence of clinical and laboratory signs of hematopoietic recovery and persistent enterocolitis at day 14 after the manipulation (Visit 15). While the patient remains in the hospital and continues treatment according to requirements of standard therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: allogeneic MMSCs infusion
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of serious adverse events (SAEs) and serious adverse reactions (SARs)
Time Frame: 2 weeks after treatment
2 weeks after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time of hematopoietic recovery
Time Frame: Follow up to completion (up to 3 months after treatment)
Monitoring of time of hematopoietic recovery assessed by complete blood count
Follow up to completion (up to 3 months after treatment)
Neutropenic enterocolitis
Time Frame: Follow up to completion (up to 3 months after treatment)
Monitoring of frequency (number of participants) and severity of neutropenic enterocolitis during the study period
Follow up to completion (up to 3 months after treatment)
Infectious complications
Time Frame: Follow up to completion (up to 3 months after treatment)
Monitoring of frequency and severity of infectious complications during the study period. Frequency of infectious complications will be represented in number of infections verified by clinical, instrumental examination and/or laboratory methods.
Follow up to completion (up to 3 months after treatment)
Transfusion needs
Time Frame: Follow up to completion (up to 3 weeks after treatment)
Monitoring of frequency (number of participants) of transfusion needs during neutropenic period
Follow up to completion (up to 3 weeks after treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Burnasyan Federal Medical Biophysical Center

Investigators

  • Principal Investigator: Zaryi Simavonyan, MD, Burnasyan Federal Medical Biophysical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Anticipated)

June 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

May 21, 2014

First Submitted That Met QC Criteria

May 22, 2014

First Posted (Estimate)

May 23, 2014

Study Record Updates

Last Update Posted (Estimate)

June 10, 2015

Last Update Submitted That Met QC Criteria

June 9, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RU-FMBC-05-01-14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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