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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-005533-32 | EudraCT Number |
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| Name | Class |
|---|---|
| Andalusian Initiative for Advanced Therapies | OTHER_GOV |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Allogeneic Mesenchymal Cells | Experimental | All patients will receive Adult Allogeneic Mesenchymal Cell from adipose tissue. It is not considered ethical the inclusion of a control group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adult Allogeneic Mesenchymal cells from adipose tissue. | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Teresa Caballero, Hematologist | Virgen del Rocio University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Universitaria de Navarra, Av Pio XII ,36 | Pamplona | Navarre | 31008 | Spain | ||
| Hospital Universitario Reina Sofía |
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| Córdoba |
| Spain |
| Hospital Regional Universitario de Málaga | Málaga | Spain |
| Hospital Clínico Universitario Virgen de la Arrixaca | Murcia | 30120 | Spain |
| Hospital clinico universitario de salamanca | Salamanca | 37007 | Spain |
| Virgen del Rocio University Hospital, av. Manuel Siurot s/n | Seville | 41013 | Spain |