A phase 1, open-label study to determine safety and tolerability of the topical application of mesenchymal stem/stromal cell (MSC) exosome ointment to treat psoriasis in healthy volunteers

• Published in: Cytotherapy (Oxford, England) Vol. 27; no. 5; pp. 633 - 641
• Main Authors: Chandran, Nisha Suyien, Bhupendrabhai, Monil Nagad, Tan, Thong Teck, Zhang, Bin, Lim, Sai Kiang, Choo, Andre Boon Hwa, Lai, Ruenn Chai
• Format: Journal Article
• Language: English
• Published: England Elsevier Inc 01.05.2025
• Subjects: Administration, Topical; Adult; Advanced Basic Science; COVID-19; Exosome; Exosomes - transplantation; Female; Healthy Volunteers; Humans; Male; Mesenchymal Stem Cell Transplantation; Mesenchymal Stem Cells - cytology; Mesenchymal Stem Cells - metabolism; Mesenchymal stem/stromal cells (MSCs); Middle Aged; Ointments - administration & dosage; Ointments - adverse effects; Other; Psoriasis; Psoriasis - therapy; Young Adult; SCORAD; Psoriasis; AE; FTU; IP; EOS; VAS; Mesenchymal stem/stromal cells (MSCs); IMQ; ICF; TID; ICH; SD; TEAE; Exosome; GCP; SAE; HAS; GRAS; MSC; CIOMS; CFB; End of Study; Imiquimod; Visual Assessment Score; Standard Deviation; Treatment-emergent Adverse Event; ter in die (thrice a day); Adverse Event; International Conference on Harmonization; Health Sciences Authority; Generally Recognized as Safe; Change from Baseline; Informed Consent Form; Scoring Atopic Dermatitis; Serious Adverse Event; Mesenchymal Stem/stromal Cell; Good Clinical Practice; Investigational Product; Council for International Organizations of Medical Sciences; Fingertip Unit

Topical application of mesenchymal stem/stromal cell (MSC) exosomes have yielded encouraging results in the treatment of psoriasis in pre-clinical studies. The safety of topical applications of MSC exosome in ointment has not yet been determined in human subjects. To assess the safety and tolerabili...