Sequential Administration of WJ-MSCs for the Treatment of GvHD Refractory to Second Line Treatment

Launched by FUNDACIÓN OFTALMOLÓGICA DE SANTANDER CLÍNICA CARLOS ARDILA LULLE · Mar 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with Graft versus Host Disease (GVHD), a serious condition that can occur after a stem cell transplant. Researchers are specifically looking at the use of Wharton's jelly mesenchymal stem cells (WJ-MSCs), which are special cells that might help improve the condition in patients whose GVHD has not responded to standard treatments, including a medication called ruxolitinib. The goal is to see if giving these stem cells in a specific sequence can be safe and effective for patients who are facing this difficult situation.

To be eligible for the trial, patients need to be between 18 and 65 years old and must have had a stem cell transplant due to blood cancers. They should also have GVHD that hasn't improved with second-line treatments. Some health criteria, like good heart and lung function, will be checked to ensure participants can safely tolerate the treatment. If someone participates, they can expect to receive these stem cells and be closely monitored for any effects. The trial is currently not yet recruiting participants, but it aims to provide hope for those struggling with treatment-resistant GVHD.

Gender

ALL

Eligibility criteria

• Inclusion criteria:
• • Aged between 18 and 65 years.
• • With a diagnosis of malignant hemopathies, who have undergone allogeneic HSCT and who are diagnosed with acute GVHD refractory to second-line treatment.
• • Patients who have received bone marrow and/or peripheral blood as a source of cells.
• • Patients who have received cells from a family or unrelated donor
• • Myeloablative or non-myeloablative conditioning method.
• • Adequate cardiac function without evidence of uncontrolled hypertension, congestive heart failure, angor pectoris, or acute myocardial infarction in the 6 months prior to the process.
• • Adequate lung function without evidence of severe obstructive or restrictive lung disease.
• • Informed consent signed by the patient.
• Exclusion Criteria:
• • Patients from the Transplant Unit of the FOSCAL.
• • Patients with a diagnosis of hemopathy that has not been controlled by the transplant or is progressing at the time of treatment.
• • Bacterial, viral, or fungal infection that is not being controlled with adequate treatment.
• • Cardiac and/or pulmonary function in uncontrolled altered conditions.
• • According to medical criteria, patients who are not in an adequate situation to tolerate the treatment.
• • Pregnant women or women at risk of pregnancy due to inadequate contraceptive measures.