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

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: Effectiveness and Safety of Intravenous Infusion of Bone Marrow Derived Allogeneic Multipotent Mesenchymal Stromal Cells for Enhancing Hematopoietic Recovery and Prophylaxis of N

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 Summary:

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.

Sponsor: Burnasyan Federal Medical Biophysical Center

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

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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
• 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
• 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.
• 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

Original Secondary Outcome:

• 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
• Neutropenic enterocolitis [ Time Frame: Follow up to completion (up to 3 months after treatment) ]
  Monitoring of frequency and severity of neutropenic enterocolitis during the study period
• 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
• Transfusion needs [ Time Frame: Follow up to completion (up to 3 weeks after treatment) ]
  Monitoring of frequency of transfusion needs during neutropenic period

Information By: Burnasyan Federal Medical Biophysical Center

Dates:
Date Received: May 21, 2014
Date Started: May 2014
Date Completion: December 2016
Last Updated: June 9, 2015
Last Verified: June 2015