Clinical Trial With MSC for Graft Versus Host Disease Treatment

NCT ID: NCT02687646

Last Updated: 2022-10-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-20
• Study Completion Date: 2022-01-21

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.

Conditions

Acute Graft Versus Host Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Allogeneic Mesenchymal Cells

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

Group Type: EXPERIMENTAL

Adult Allogeneic Mesenchymal cells from adipose tissue.

Intervention Type: DRUG

Study treatment consists of Mesenchymal Stem Cell (MSC) derived from donors adipose tissue and expanded in vitro in a specific medium with platelet lysate without addition of animal derived products.

Subjects will receive four sequential IV dose of Mesenchymal stem cells.

Sequential doses:

Day 1: 0.7-1 x 106 MSC / kg Day 4: 0.7-1 x 106 MSC / kg Day 11: 0.7-1 x 106 MSC / kg Day 18: 0.7-1 x 106 MSC / kg

Interventions

Adult Allogeneic Mesenchymal cells from adipose tissue.

Study treatment consists of Mesenchymal Stem Cell (MSC) derived from donors adipose tissue and expanded in vitro in a specific medium with platelet lysate without addition of animal derived products.

Subjects will receive four sequential IV dose of Mesenchymal stem cells.

Sequential doses:

Day 1: 0.7-1 x 106 MSC / kg Day 4: 0.7-1 x 106 MSC / kg Day 11: 0.7-1 x 106 MSC / kg Day 18: 0.7-1 x 106 MSC / kg

Intervention Type: DRUG

Other Intervention Names

MSC for the treatment of graft -versus -host disease

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. -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Andalusian Initiative for Advanced Therapies

OTHER_GOV

Sponsor Role: collaborator

Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Teresa Caballero, Hematologist

Role: STUDY_DIRECTOR

Virgen del Rocio University Hospital

Locations

Clinica Universitaria de Navarra, Av Pio XII ,36

Pamplona, Navarre, Spain

Hospital Universitario Reina Sofía

Córdoba, , Spain

Hospital Regional Universitario de Málaga

Málaga, , Spain

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, , Spain

Hospital clinico universitario de salamanca

Salamanca, , Spain

Virgen del Rocio University Hospital, av. Manuel Siurot s/n

Seville, , Spain

Countries

Spain

Other Identifiers

2014-005533-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MSC-EICH-2014

Identifier Type: -

Identifier Source: org_study_id