Clinical trial NCT02687646: Clinical Trial With MSC for Graft Versus Host Disease Treatment
Official title: Clinical Trial Phase I / II Graft Versus Host Disease Treatment Refractory to First-line Therapy With Sequential Infusion of Mesenchymal Cells Allogeneic Expanded Adipose Tissue in Vitro
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Acute Graft Versus Host Disease
Lead sponsor: Andalusian Network for Design and Translation of Advanced Therapies
Sponsor class: OTHER
Collaborators: name: Andalusian Initiative for Advanced Therapies
First posted: 2016-02-22
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Sequential administration of MSCs obtained from adipose tissue is an effective and safe treatment for acute graft versus host disease refractory to first-line treatment. Furthermore the infusion of these cells produces a biological pattern in patients that relates to the clinical response.

Detailed description: Multicenter, open, non -controlled clinical trial. It is a phase I-II trial to assess the safety and efficacy of sequential infusion of allogeneic MSCs from adipose tissue, expanded "in vitro" platelet lysate in the treatment of patients undergoing hematopoietic stem cell trasplantation, who have developed a refractory graft versus host disease to first line of treatment.

This is a prospective, multicenter, open to patients undergoing allogeneic transplantation in Spanish hospitals, with one cohort of patients who receive four sequential doses of MSC.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of ≥ grade II Graft Versus Host Disease refractory to first-line treatment.
2. Having been subjected to hematopoietic Stem Cell Transplantation as treatment for malignant blood disorder has been controlled by the transplantation. The source may have been bone marrow cells or peripheral blood (PB) and coming from a family member or unrelated donor.
3. Having been transplanted with myeloablative or non-myeloablative conditioning.
4. normal cardiac function (EF ≥ 40%) without evidence of uncontrolled hypertension, congestive heart failure, angina pectoris or myocardial infarction within 6 months prior to the process
5. Lung function without evidence of severe obstructive or restrictive lung disease.
6. Age between 18 and 65 years.
7. Women of childbearing age considered until one year after the last menstrual period and which have not undergone a surgical sterilization must obtain a negative pregnancy test at the time of inclusion in the study and commit to use a medically approved birth control while on study.
8. normal cardiac function (EF ≥ 40%) without evidence of uncontrolled hypertension, congestive heart failure, angina pectoris or myocardial infarction within 6 months prior to the process.
9. Signature of informed consent -

Exclusion Criteria:

1. uncontrolled blood disorder by transplantation or progression at the time of inclusion.
2. bacterial, viral, fungal or is not being controlled.
3. Any circumstance that the proposed trial dissuade medical treatment. Pregnancy, lactation or refusal to use safe contraceptive measures.
4. Patients who are currently participating or have completed their participation in a clinical trial in less than 3 months or who have participated in a clinical trial of Advanced Therapies at any previous time period.
5. Patients who are currently participating or have completed their participation in a clinical trial in a period shorter than 3 months or who have participated in a clinical trial of Advanced Therapies at any previous time.
6. positive serology for Hepatitis B , Hepatitis C and AIDS Virus. -

Primary outcomes:
measure: Safety measured by incidence of serious adverse events
timeFrame: 2 years
Secondary outcomes:
measure: Effectiveness measured by answer of refractory acute graft disease against host to first-line treatment
timeFrame: 2 years
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra, Av Pio XII ,36
state: Navarra
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Murcia
country: Spain
facility: Hospital Clínico Universitario Virgen de la Arrixaca
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Málaga
city: Salamanca
country: Spain
facility: Hospital clinico universitario de salamanca
city: Sevilla
country: Spain
facility: Virgen del Rocio University Hospital, av. Manuel Siurot s/n
Study officials:
affiliation: Virgen del Rocio University Hospital
name: Teresa Caballero, Hematologist
role: STUDY_DIRECTOR
References: