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

Burnasyan Federal Medical Biophysical Center

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Neutropenic Enterocolitis

Myeloablative Chemotherapy Induced Bone Marrow Aplasia

Treatments

Drug: Bone marrow derived allogeneic MMSCs infusion

Procedure: Autologous peripheral blood stem cells infusion

Drug: High-dose chemotherapy

Procedure: Peripheral blood stem cell mobilisation and collection

Study type

Interventional

Funder types

Other

Identifiers

NCT02145923

RU-FMBC-05-01-14

Details and patient eligibility

About

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.

Full 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.

Enrollment

16 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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