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Clinical Trial With MSC for Graft Versus Host Disease Treatment

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ClinicalTrials.gov Identifier: NCT02687646
Recruitment Status : Recruiting
First Posted : February 22, 2016
Last Update Posted : September 24, 2019
Sponsor:
Collaborator:
Andalusian Initiative for Advanced Therapies
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Acute Graft Versus Host Disease Drug: Adult Allogeneic Mesenchymal cells from adipose tissue. Phase 1 Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: 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 Start Date : May 2016
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020


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 Name: MSC for the treatment of graft -versus -host disease




Primary Outcome Measures :
  1. Safety measured by incidence of serious adverse events [ Time Frame: 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 :
  1. Effectiveness measured by answer of refractory acute graft disease against host to first-line treatment [ Time Frame: 2 years ]

    Effectiveness will be measured in terms of:

    Answer of refractory acute graft disease against host to first-line treatment




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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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. -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02687646


Contacts
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Contact: Teresa Caballero Velazquez, Hematologist +34 955 013256 t.c.velazquez@gmail.com
Contact: Ana Cardesa Gil, Chemistry +34 955048366 ana.cardesa@juntadeandalucia.es

Locations
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Spain
Clinica Universitaria de Navarra, Av Pio XII ,36 Not yet recruiting
Pamplona, Navarra, Spain, 31008
Contact: Paula Rodriguez Otero, Hematologist    +34 948 296 397    paurodriguez@unav.es   
Contact: Felipe Prosper, Chief of Hematology       fprosper@unav.es   
Sub-Investigator: Paula Rodriguez Otero, Hematologist         
Sub-Investigator: Enrique Andreu, Biologist         
Sub-Investigator: Felipe Prosper, Hematologist         
Sub-Investigator: Jose Rifont Roca, Hematologist         
Hospital Universitario Reina Sofía Recruiting
Córdoba, Spain
Contact: Inmaculada Concepción Herrera Arroyo, MD       inmaculada.herrera.sspa@juntadeandalucia.es   
Principal Investigator: Inmaculada Concepción Herrera Arroyo         
Sub-Investigator: Carmen Martín Calvo         
Sub-Investigator: Rafael Rojas Contreras         
Sub-Investigator: Estefanía García Torres         
Hospital Clínico Universitario Virgen de la Arrixaca Recruiting
Murcia, Spain, 30120
Contact: Miguel Blanquer Blanquer, MD       miguelblanquer@gmail.com   
Principal Investigator: Miguel Blanquer Blanquer         
Sub-Investigator: Jose María Moraleda Jiménez         
Sub-Investigator: Andrés Sánchez Salinas         
Sub-Investigator: Jorge Montserrat Coll         
Sub-Investigator: Ana García Hernández         
Sub-Investigator: Darío Sánchez Slinas         
Sub-Investigator: Carmen Algueró Martín         
Sub-Investigator: Francisco Iniesta Martínez         
Hospital Regional Universitario de Málaga Recruiting
Málaga, Spain
Contact: Mª Ángeles Cuesta Casas, MD       cuestamarian@hotmail.com   
Principal Investigator: Mª Ángeles Cuesta Casas         
Sub-Investigator: Alejandro Contento Gonzalo         
Sub-Investigator: Isabel Vidales Mancha         
Sub-Investigator: MªJesús Pascual Gascón         
Hospital clinico universitario de salamanca Recruiting
Salamanca, Spain, 37007
Contact: Lucia Lopez Corral, Hematologist    +34 923 291316    lucialopezcorral@usal.es   
Contact: Consuelo Del Cañizo, Chief of Hematology         
Sub-Investigator: Lucia Lopez Corral, Hematologist         
Sub-Investigator: Felipe Prosper, Hematologist         
Sub-Investigator: Lourdes Vazquez, Hematologist         
Sub-Investigator: Mª Dolores Caballlero, Hematologist         
Sub-Investigator: Alba Redondo, Hematologist         
Sub-Investigator: Fermin Sanchez Guijo, Hematologist         
Sub-Investigator: Olga Lopez Villar, Hematologist         
Virgen del Rocio University Hospital, av. Manuel Siurot s/n Recruiting
Sevilla, Spain, 41013
Contact: Teresa Caballero Velazquez, Chief of Hematology    955 013256    t.c.velazquez@gmail.com   
Contact: Jose Antonio Perez Simon, Hematogist    955 01 32 60    josea.perez.simon.sspa@juntadeandalucia.es   
Principal Investigator: Teresa Caballero Velazquez, Hematologist         
Sub-Investigator: Jose Antonio Perez Simon, Hematologist         
Sub-Investigator: Cristina Calderon Cabrera, Hematologist         
Sub-Investigator: Isabel Montero Cuadrado, Hematologist         
Sub-Investigator: Isabel Alvarez Laderas, Hematologist         
Sub-Investigator: Estefania Garcia Guerrero, Hematologist         
Sub-Investigator: Estrella Carrillo, Hematologist         
Sub-Investigator: Rosario Morales, Hematologist         
Sponsors and Collaborators
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
Andalusian Initiative for Advanced Therapies
Investigators
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Study Director: Teresa Caballero, Hematologist Virgen del Rocio University Hospital

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Responsible Party: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
ClinicalTrials.gov Identifier: NCT02687646     History of Changes
Other Study ID Numbers: MSC-EICH-2014
2014-005533-32 ( EudraCT Number )
First Posted: February 22, 2016    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Graft vs Host Disease
Immune System Diseases