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Phase I-II, Multicenter, Randomized, Controlled, Proof of Concept Clinical Trial to determine feasibility, safety and efficacy of the use of Allogenic adipose-derived adult mesenchymal stem cells expanded on fibrinhyaluronic biological matrix in the treatment of venous ulcer of the lower limbs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bioengineered Artificial Mesenchimal Sheet (BAMS) | Experimental | Allogenic adipose-derived adult mesenchymal stem cells expanded on fibrinhyaluronic biological matrix |
|
| Standard treatment (Control) | Active Comparator | Standard treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bioengineered Artificial Mesenchimal Sheet (BAMS) | Biological | Each patient assigned to the experimental treatment group will receive 4 BAMS (1 BAMS/week) at a concentration of about 360,000 cells/cm2. |
| Measure | Description | Time Frame |
|---|---|---|
| Factibility of Bioengineered Artificial Mesenchimal Sheet measured as the remission of the treated fistula. | To evaluate the factibility of the topical application of CMTAd in a biological matrix of fibrin-hyaluronic acid on venous ulcers (VU). | Through study completion, an average of 1 year |
| Safety of Bioengineered Artificial Mesenchimal Sheet measured by the incidence of adverse events | To examine the safety of cutaneous administration of CMTAd in a biological matrix of fibrin-hyaluronic acid on VUs compared to standard treatment. | Through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Olga Férnández López, PhD | Contact | 955 048 366 | 0034 | ensayosclinicos.radytta.fps@juntadeandalucia.es |
| Name | Affiliation | Role |
|---|---|---|
| Encarnación González Vigil | Unidad de A.P. de Atarfe | Principal Investigator |
| Mª Ángeles Granado Contrelas | Unidad de A.P. de Alfacar | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unidad de A.P. de Alfacar | Recruiting | Alfacar | Granada | 18170 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40373055 | Derived | Costela-Ruiz VJ, Gonzalez-Vigil E, Espinosa-Ibanez O, Alcazar-Caballero RM, Melguizo-Rodriguez L, Fernandez-Lopez O, Arias-Santiago S. Application of allogeneic adult mesenchymal stem cells in the treatment of venous ulcers: A phase I/II randomized controlled trial protocol. PLoS One. 2025 May 15;20(5):e0323173. doi: 10.1371/journal.pone.0323173. eCollection 2025. |
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| Standard treatment (Control) | Procedure | Each patient assigned to the control group will undergo a standard treatment procedure for uncomplicated venous ulcers. |
|
| Victor Costela Ruiz |
| Universidad de Granada |
| Study Director |
| Unidad de A.P. de Atarfe | Recruiting | Atarfe | Granada | 18290 | Spain |
|
| Universidad de Granada | Recruiting | Granada | 18071 | Spain |
|
| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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