Clinical Trial With Adipose Tissue Stem Cells on Biological Matrix for the Treatment of Venous Ulcer of the Lower Limbs
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|ClinicalTrials.gov Identifier: NCT05962931|
Recruitment Status : Recruiting
First Posted : July 27, 2023
Last Update Posted : July 27, 2023
|Condition or disease||Intervention/treatment||Phase|
|Venous Ulcer||Biological: Bioengineered Artificial Mesenchimal Sheet (BAMS) Procedure: Standard treatment (Control)||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||July 12, 2023|
|Estimated Primary Completion Date :||July 2025|
|Estimated Study Completion Date :||July 2025|
Experimental: Bioengineered Artificial Mesenchimal Sheet (BAMS)
Allogenic adipose-derived adult mesenchymal stem cells expanded on fibrinhyaluronic biological matrix
Biological: Bioengineered Artificial Mesenchimal Sheet (BAMS)
Each patient assigned to the experimental treatment group will receive 4 BAMS (1 BAMS/week) at a concentration of about 360,000 cells/cm2.
Active Comparator: Standard treatment (Control)
Procedure: Standard treatment (Control)
Each patient assigned to the control group will undergo a standard treatment procedure for uncomplicated venous ulcers.
- Factibility of Bioengineered Artificial Mesenchimal Sheet measured as the remission of the treated fistula. [ Time Frame: Through study completion, an average of 1 year ]To evaluate the factibility of the topical application of CMTAd in a biological matrix of fibrin-hyaluronic acid on venous ulcers (VU).
- Safety of Bioengineered Artificial Mesenchimal Sheet measured by the incidence of adverse events [ Time Frame: Through study completion, an average of 1 year ]To examine the safety of cutaneous administration of CMTAd in a biological matrix of fibrin-hyaluronic acid on VUs compared to standard treatment.
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): NCT05962931
|Contact: Olga Férnández López, PhD||955 048 366 ext email@example.com|
|Unidad de A.P. de Alfacar||Recruiting|
|Alfacar, Granada, Spain, 18170|
|Contact: Mª Ángeles Granado Contrelas|
|Unidad de A.P. de Atarfe||Recruiting|
|Atarfe, Granada, Spain, 18290|
|Contact: Encarnación González Vigil|
|Universidad de Granada||Recruiting|
|Granada, Spain, 18071|
|Contact: Victor Costela Ruiz|
|Principal Investigator:||Encarnación González Vigil||Unidad de A.P. de Atarfe|
|Principal Investigator:||Mª Ángeles Granado Contrelas||Unidad de A.P. de Alfacar|
|Study Director:||Victor Costela Ruiz||Universidad de Granada|