Clinical Trial With MSC for Graft Versus Host Disease Treatment

Phase 1

Completed

• Conditions: Acute Graft Versus Host Disease
• Interventions: Drug: Adult Allogeneic Mesenchymal cells from adipose tissue.

• Registration Number: NCT02687646
• Lead Sponsor: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud

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.

Study Timeline

• Study First Submitted: 2016-01-19
• Study First Submitted QC: 2016-02-19
• Study First Posted: 2016-02-22
• Study Start: 2017-02-20
• Primary Completion: 2022-01-21
• Study Completion: 2022-01-21
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-10
• Last Update Posted: 2022-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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. -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Allogeneic Mesenchymal Cells	Adult Allogeneic Mesenchymal cells from adipose tissue.	All patients will receive Adult Allogeneic Mesenchymal Cell from adipose tissue. It is not considered ethical the inclusion of a control group.

Primary Outcome Measures

Name	Time	Method
Safety measured by incidence of serious adverse events	2 years	Safety will be measured in terms of: Incidence of Serious Adverse Events after at the time of the infusion of study drug or during follow-up.

Secondary Outcome Measures

Name	Time	Method
Effectiveness measured by answer of refractory acute graft disease against host to first-line treatment	2 years	Effectiveness will be measured in terms of: Answer of refractory acute graft disease against host to first-line treatment

Trial Locations

Locations (6)

Hospital Regional Universitario de Málaga; 🇪🇸 Málaga, Spain

Clinica Universitaria de Navarra, Av Pio XII ,36; 🇪🇸 Pamplona, Navarra, Spain

Hospital clinico universitario de salamanca; 🇪🇸 Salamanca, Spain

Hospital Universitario Reina Sofía; 🇪🇸 Córdoba, Spain

Hospital Clínico Universitario Virgen de la Arrixaca; 🇪🇸 Murcia, Spain

Virgen del Rocio University Hospital, av. Manuel Siurot s/n; 🇪🇸 Sevilla, Spain