Clinical trial · Interventional
Effectiveness and Safety of MMSCs for Enhancing Hematopoietic Recovery and Prophylaxis of Neutropenic Enterocolitis
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myeloablative Chemotherapy Induced Bone Marrow Aplasia | — | UNRESOLVED | — |
| Neutropenic Enterocolitis | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous peripheral blood stem cells infusion | Procedure | — | UNRESOLVED |
| Bone marrow derived allogeneic MMSCs infusion | Drug | — | UNRESOLVED |
| High-dose chemotherapy | Drug | Chemotherapy | ALIAS |
| Peripheral blood stem cell mobilisation and collection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- allogeneic MMSCs infusion
- description
- 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.
- interventionNames
- Procedure: Peripheral blood stem cell mobilisation and collection
- Drug: High-dose chemotherapy
- Drug: Bone marrow derived allogeneic MMSCs infusion
- Procedure: Autologous peripheral blood stem cells infusion
Primary outcomes (1)
- measure
- Number of serious adverse events (SAEs) and serious adverse reactions (SARs)
- timeFrame
- 2 weeks after treatment
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
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