Evaluation therapeutic effect of conditioned medium from 3D culture mesenchymal stem cell spheroids serum for Vitiligo: clinical trial phase 1

Evaluation of topical serum containing mesenchymal stem cell conditioned media on patients with vitiligo

A clinical trial with control groups, parallel assignment, single-blind, simple randomized, phase 1 on 20 patients. To avoid disparity between group sizes, we will use replacement randomization until we achieve a balanced group size

The study will be performed at the skin and stem cell research center, Tehran University of Medical Sciences. The intervention area will receive a serum with adipose-derived mesenchymal stem cell conditioned medium and the control group will receive serum without the conditioned medium. The evaluation will be continued twice a day for 45 days.

Inclusion Criteria: 18 Years and older, diagnosis of Vitiligo - Generalized vitiligo involving both sides of the body in one or more areas of the body (limbs, trunk, etc.), be able to understand the requirements of the study, and be able to sign an informed consent form, agree to follow the terms of the study and follow-up, lack of corticosteroid-based treatment. Exclusion Criteria: Pregnant females, infection in the donor site, Kubner's evidence in the past, keloidal tendency, patients with focal or segmental vitiligo, patients with vitiligo that affects more than 30% of their body surface, patients who self-reported HIV or hepatitis C, patients self-reported having uncontrolled diabetes mellitus

Patients are randomly selected. Two active plaques will be selected by a physician on two separate areas of the body. The intervention area will receive a serum containing 3% adipose-derived mesenchymal stem cell conditioned medium and another plaque will receive serum without conditioned medium as a control group.

Change to baseline in repigmentation

Simple randomization, this method is equivalent to tossing a coin for each subject that enters a trial, such as Heads = Active, Tails = Placebo. Implementation and treatment of assignments are completely unpredictable.

Only the researcher doing the study knows which treatment or intervention the participant is receiving until the trial is over.

All data collected for the primary outcome

Data relative to the time after finishing the data collection and 3 months after publication

Available for people working in an academic institution

There are no specific criteria

People can send an email to the responsible person (Dr. Mahsa Mollapour Sisakht) to get more information

After requesting the data, you will get an email with the information (Email address: mahsamollapour@gmail.com)