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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02145923
Recruitment Status : Unknown
Verified June 2015 by Zarui Simavonyan, Burnasyan Federal Medical Biophysical Center.
Recruitment status was:  Enrolling by invitation
First Posted : May 23, 2014
Last Update Posted : June 10, 2015
Sponsor:
Information provided by (Responsible Party):
Zarui Simavonyan, Burnasyan Federal Medical Biophysical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Neutropenic Enterocolitis Myeloablative Chemotherapy Induced Bone Marrow Aplasia Procedure: Peripheral blood stem cell mobilisation and collection Drug: High-dose chemotherapy Drug: Bone marrow derived allogeneic MMSCs infusion Procedure: Autologous peripheral blood stem cells infusion Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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.
Study Start Date : May 2014
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Number of serious adverse events (SAEs) and serious adverse reactions (SARs) [ Time Frame: 2 weeks after treatment ]

Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02145923


Locations
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Russian Federation
State Research Center Burnasyan Federal Medical Biophysical Center FMBA of Russia
Moscow, Russian Federation, 123182
Sponsors and Collaborators
Burnasyan Federal Medical Biophysical Center
Investigators
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Principal Investigator: Zaryi Simavonyan, MD Burnasyan Federal Medical Biophysical Center
Principal Investigator: Ilya I Eremin, MD, PhD Burnasyan Federal Medical Biophysical Center
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Responsible Party: Zarui Simavonyan, MD, Burnasyan Federal Medical Biophysical Center
ClinicalTrials.gov Identifier: NCT02145923    
Other Study ID Numbers: RU-FMBC-05-01-14
First Posted: May 23, 2014    Key Record Dates
Last Update Posted: June 10, 2015
Last Verified: June 2015
Keywords provided by Zarui Simavonyan, Burnasyan Federal Medical Biophysical Center:
Hodgkin Lymphoma
Non-Hodgkin's Lymphomas
Allogeneic Mesenchymal Stem Cell Transplantation
Autologous Peripheral Blood Stem Cell Transplantation
Neutropenic Enterocolitis
Myeloablative Chemotherapy
Bone Marrow Aplasia
Additional relevant MeSH terms:
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Enterocolitis
Enterocolitis, Neutropenic
Anemia, Aplastic
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Anemia
Hematologic Diseases
Bone Marrow Failure Disorders
Bone Marrow Diseases