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A naturally secreted, embryonic-like human cell conditioned media (hCCM) used as a follicle holding solution (FHS) holds promise for improving outcomes of hair transplantation surgery, according to clinical trial findings reported by Neil S. Sadick, M.D., at the 2011 annual meeting of the American Society for Dermatologic Surgery.
The FHS is produced through growth of neonatal-derived fibroblasts, which are obtained from cell banks. The fibroblasts are grown in suspension cultures placed in closed bioreactors under low oxygen conditions that simulate the embryonic environment.
In this setting, the cells are induced to express numerous cell surface markers associated with follicular stem cells, and they also secrete numerous proteins and growth factors into the culture media, including Wnt7a, keratinocyte growth factor, vascular endothelial growth factor, noggin and follistatin, all of which have been shown to stimulate hair growth.
"The early experience from this clinical trial indicates use of the hCCM for holding the extracted grafts may have benefits for both improving the immediate cosmetic result after hair transplantation as well as the long-term outcome," he says.
At the ASDS meeting, Dr. Sadick presented preliminary outcomes from a prospective, split-side controlled clinical trial comparing outcomes of transplantation using grafts placed in the FHS or phosphate buffered saline (PBS). So far, 14 patients have been enrolled at three centers. Average soaking time for the grafts was 2.4 hours, and the average number of chubby grafts transplanted per recipient site was 1,005.
Analyses from data collected at 12 weeks show that on average, 52 percent of hairs placed in PBS were lost to effluvium, whereas the shedding rate for the FHS transplants was only 15 percent. FHS soaking also appeared to be associated with improved post-transplant hair quality, Dr. Sadick says.
In vitro experiments and animal studies were undertaken initially for proof of concept. Excess human follicular units (HFUs) cultured in FHS showed increased viability and growth after 24 and 72 hours relative to controls cultured in phosphate buffered saline.
In addition, trichogenic human keratinocytes and fibroblasts maintained in culture with FHS remained viable and continued to grow for at least two months, while cells removed after four weeks for transplantation into mice resulted in the appearance of hair shafts and structures resembling hair follicles. FHS was also shown to stimulate hair growth in cultured chubby follicles.
Based on its content of biologically active factors and the preclinical study findings, the embryonic-like hCCM is also being investigated for other applications in the management of hair loss disorders. A more concentrated formulation of the hCCM, known as hair stimulating complex (HSC), is being studied as an intradermal injectable treatment for androgenetic alopecia in men, and a study of intradermal HSC in women with androgenetic alopecia will be launched soon. A clinical trial is also under way to investigate whether topical application of a gel containing FHS might improve healing of problematic donor sites in hair transplant patients, Dr. Sadick says.
"So far, results from studies evaluating FSC injection for treatment of male pattern baldness show that it is safe and promotes growth of viable hair follicles, and early results from topical application of the FHS to dehisced donor sites indicate the formulation may improve wound closure and reduce scarring," he says.
Disclosures: Dr. Sadick is on the medical advisory board for Histogen and holds corporate stock options.