Clinical Trial to Evaluate Safety and Efficiency of Mesenchymal Stem Cell in Patients With Hidradenitis Suppurativa
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05934825|
Recruitment Status : Recruiting
First Posted : July 7, 2023
Last Update Posted : July 7, 2023
|Condition or disease||Intervention/treatment||Phase|
|Hidradenitis Suppurativa||Biological: Injectable suspension of allogeneic adult mesenchymal stem cells Other: Placebo||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Multicenter Phase I/II Clinical Trial, Randomized, Double Blind, Controlled With Placebo to Evaluate Safety and Efficiency of Allogenic Adult Mesenchymal Stem Cells From Adipose Tissue in the Treatment of Draining Fistulas in Patients With Hidradenitis Suppurativa|
|Actual Study Start Date :||October 26, 2022|
|Estimated Primary Completion Date :||October 26, 2025|
|Estimated Study Completion Date :||October 26, 2025|
Experimental: Injectable suspension of allogeneic adult mesenchymal stem cells
Patients will receive an injectable suspension of allogeneic adult mesenchymal stem cells from adipose tissue intralesionally.
Biological: Injectable suspension of allogeneic adult mesenchymal stem cells
Cell therapy treatment will be administered in a single dose at the beginning of the study. The treatment consists of the administration of a single dose of allogeneic adult mesenchymal stem cells from adipose tissue. The dose is 120 million cells (drug volume: 20 ml, concentrated at 6 million cels/ml).
Placebo Comparator: Placebo
Patients will receive the cell-free suspension vehicle: 49% DMEM without phenol red, 1% L-Alanine LGlutamine and 50% hyaluronic acid
The placebo consists of the administration of the excipient of the suspension without cells. The excipient is a mixture of 50% hyaluronic acid, 49% DMEM without phenol red and 1% L-Alanine-L Glutamine.
- Safety of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Adverse Event Rate [ Time Frame: 24 months ]To determine the safety of intralesional administration of allogeneic mesenchymal cells in draining fistulas in patients with hidradenitis suppurativa
- Efficacy of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Survival Rate [ Time Frame: 23 months ]To evaluate the efficacy of intralesional administration of human allogeneic mesenchymal cells versus the control group, in terms of combined remission of the draining fistula.
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): NCT05934825
|Contact: María del Mar Macías Sánchez||671 533 email@example.com|
|Hospital Universitario Virgen de Las Nieves||Recruiting|
|Granada, Spain, 18014|
|Contact: ALEJANDRO MOLINA LEYVA firstname.lastname@example.org|