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

Neutropenic Enterocolitis Clinical Trial

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.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02145923
• Other study ID #: RU-FMBC-05-01-14
• Status: Enrolling by invitation
• Phase: Phase 1/Phase 2
• First received: May 21, 2014
• Last updated: June 9, 2015
• Start date: May 2014
• Est. completion date: December 2016

Study information

• Verified date: June 2015
• Source: Burnasyan Federal Medical Biophysical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 16
• Est. completion date: December 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anemia, Aplastic
• Enterocolitis
• Myeloablative Chemotherapy Induced Bone Marrow Aplasia
• Neutropenic Enterocolitis
• Pancytopenia

Intervention

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)
• Bone marrow derived allogeneic MMSCs infusion

Procedure:
• Autologous peripheral blood stem cells infusion

Locations

Country	Name	City	State
Russian Federation	State Research Center Burnasyan Federal Medical Biophysical Center FMBA of Russia	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Burnasyan Federal Medical Biophysical Center

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of serious adverse events (SAEs) and serious adverse reactions (SARs)		2 weeks after treatment	Yes
Secondary	Time of hematopoietic recovery	Monitoring of time of hematopoietic recovery assessed by complete blood count	Follow up to completion (up to 3 months after treatment)	No
Secondary	Neutropenic enterocolitis	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)	No
Secondary	Infectious complications	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)	No
Secondary	Transfusion needs	Monitoring of frequency (number of participants) of transfusion needs during neutropenic period	Follow up to completion (up to 3 weeks after treatment)	No