Clinical Trial With MSC for Graft Versus Host Disease Treatment

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Graft Versus Host Disease
• Intervention / Treatment: Drug: Adult Allogeneic Mesenchymal cells from adipose tissue.

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Spain
  • Córdoba, Spain
    • Hospital Universitario Reina Sofia
  • Murcia, Spain, 30120
    • Hospital Clínico Universitario Virgen de la Arrixaca
  • Málaga, Spain
    • Hospital Regional Universitario de Malaga
  • Salamanca, Spain, 37007
    • Hospital Clinico Universitario de Salamanca
  • Sevilla, Spain, 41013
    • Virgen del Rocio University Hospital, av. Manuel Siurot s/n
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Clinica Universitaria de Navarra, Av Pio XII ,36

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: 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.

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; Other Names: MSC for the treatment of graft -versus -host disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
• Collaborators: Andalusian Initiative for Advanced Therapies
• Investigators: Study Director: Teresa Caballero, Hematologist, Virgen del Rocio University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 20, 2017
• Primary Completion (ACTUAL): January 21, 2022
• Study Completion (ACTUAL): January 21, 2022

Study Registration Dates

• First Submitted: January 19, 2016
• First Submitted That Met QC Criteria: February 19, 2016
• First Posted (ESTIMATE): February 22, 2016

Study Record Updates

• Last Update Posted (ACTUAL): October 13, 2022
• Last Update Submitted That Met QC Criteria: October 10, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Graft vs Host Disease
• Other Study ID Numbers: MSC-EICH-2014; 2014-005533-32 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No