Clinical Trial With MSC for Graft Versus Host Disease Treatment

Acute Graft Versus Host Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02687646
• Other study ID #: MSC-EICH-2014
• Secondary ID: 2014-005533-32
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: February 20, 2017
• Est. completion date: January 21, 2022

Study information

• Verified date: October 2022
• Source: Andalusian Network for Design and Translation of Advanced Therapies
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: January 21, 2022
• Est. primary completion date: January 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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. -

Related Conditions & MeSH terms

• Acute Graft Versus Host Disease
• Graft vs Host Disease

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Spain	Hospital Universitario Reina Sofía	Córdoba
Spain	Hospital Regional Universitario de Málaga	Málaga
Spain	Hospital Clínico Universitario Virgen de la Arrixaca	Murcia
Spain	Clinica Universitaria de Navarra, Av Pio XII ,36	Pamplona	Navarra
Spain	Hospital clinico universitario de salamanca	Salamanca
Spain	Virgen del Rocio University Hospital, av. Manuel Siurot s/n	Sevilla

Sponsors (2)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety measured by incidence of serious adverse events	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.	2 years
Secondary	Effectiveness measured by answer of refractory acute graft disease against host to first-line treatment	Effectiveness will be measured in terms of: Answer of refractory acute graft disease against host to first-line treatment	2 years