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

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Burnasyan Federal Medical Biophysical Center

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