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

NCT ID: NCT02145923

Last Updated: 2015-06-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2016-12-31

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.

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.

Conditions

Neutropenic Enterocolitis; Myeloablative Chemotherapy Induced Bone Marrow Aplasia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Peripheral blood stem cell mobilisation and collection

Intervention Type: PROCEDURE

High-dose chemotherapy

Intervention Type: DRUG

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

Bone marrow derived allogeneic MMSCs infusion

Intervention Type: DRUG

Autologous peripheral blood stem cells infusion

Intervention Type: PROCEDURE

Interventions

Peripheral blood stem cell mobilisation and collection

Intervention Type: PROCEDURE

High-dose chemotherapy

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

Intervention Type: DRUG

Bone marrow derived allogeneic MMSCs infusion

Intervention Type: DRUG

Autologous peripheral blood stem cells infusion

Intervention Type: PROCEDURE

Eligibility 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.

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Burnasyan Federal Medical Biophysical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Zarui Simavonyan

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zaryi Simavonyan, MD

Role: PRINCIPAL_INVESTIGATOR

Burnasyan Federal Medical Biophysical Center

Ilya I Eremin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Burnasyan Federal Medical Biophysical Center

Locations

State Research Center Burnasyan Federal Medical Biophysical Center FMBA of Russia

Moscow, , Russia

Countries

Russia

Other Identifiers

RU-FMBC-05-01-14

Identifier Type: -

Identifier Source: org_study_id