Human stem cells are known to secrete numerous growth factors and cytokines (GF/CK) that possess important biological functions. Adult human bone marrow derived Mesenchymal Stromal Cells ("BM-MSCs") are no exception to this rule. A conditioned medium generated by different types of stem cells including BM-MSC's grown under specific culture conditions have been shown to improve various types of skin conditions. Stempeutics has developed Stempeucare™ branded as Cutisera™ from a BM-MSC derived GF/CK cocktail to enhance the rejuvenation of aging skin. Although Cutisera™ contains bioactive factors derived from adult stem cells, the formulated product does not contain any stem cells. The active ingredients have been tested for in vitro efficacy using human foreskin fibroblast cultures. They have also been tested for safety and efficacy in preclinical models, upon the successful conclusion of which, a 3 month human volunteer study was undertaken. The human study has been extremely successful and has impressively demonstrated Cutisera™'s utility as a powerful and yet soothing anti-aging skin care product suitable for all skin types. The product has been stable for more than eighteen months under cool and dry conditions. The Indian regulatory authority has approved the manufacturing and distribution of this product and it is being marketed by Cipla in India. Cutisera™ is also approved for marketing in Malaysia. Stempeutics is currently working on its market entry and go-to-market strategy for several other geographies. Stempeutics is interested in collaborating with partners who can take Cutisera™ to market in key geographies such as North America, Europe and South East Asia.

Product/Technology Highlights

The BM-MSC derived conditioned medium contains more than 200+ GFs/CKs – the conditioned medium is generated using proprietary, patent pending technology

 

These GFs/CKs are known to induce skin rejuvenation, hair growth and wound healing

 

Stempeutics has quantified 30+ GFs/CKs, a few of these are critical for skin health and hair growth

 

Process Flow

Cutisera Packing

Cutisera™– Key Features & Differentiation

Pooling : Conditioned medium used to develop Cutisera™ is generated from a novel pooling process of the cells and conditioned medium - which reduces batch to batch variability

 

Stable secretion: Patented culture process which yields a stable secretion of growth factors and cytokines in specified amounts – batch after batch Growth

 

Factors: Factors important for skin health like VEGF, TGFb1, PDGF, and IGF etc, are present in the secretome which mediate diverse skin- regenerative effects, such as antioxidant protection and anti-wrinkling effect

 

Laminin is an important component of extracellular matrix which plays a critical role in cell adhesion, communication and cutaneous regeneration. It is present in adequate quantities in the Conditioned medium

 

Filtration: Ultrafiltration / Diafiltration of cytokines by tangential flow filtration technology to selectively concentrate conditioned medium

Human Volunteer Study

Fine lines and Wrinkles – Statistically significant improvements in fine lines and wrinkles was noted by dermatological assessment

 

Age spots – Statistically significant improvements in homogenicity of age spots and evenness of skin

 

Hydration - Statistically significant improvement in hydration by dermatological as well as corneometer assessment

 

Skin elasticity – Statistically significant improvements in firmness, laxity or the skin elasticity in dermatological assessment and cutometer readings at the end of 3 months of product usage

 

Product Acceptability and tolerability - The product acceptance was observed 100% of the study population by the end of first month of product usage for its texture, fragrance, ease of application and absorption