Exosome Hair Regrowth Therapy - Los Angeles, CA
At Alvi Armani we are always actively working to optimize treatments for our patients. For years Dr. Baubac and our in-house research staff have developed solutions to combat hair loss such as topical finasteride and dutasteride, and have refined PRP treatments that have helped our patients maintain existing hair and stimulate new hair growth as well as combining PRP with our FUE hair transplant procedures for optimum results.
Alvi Armani Medical Director, Dr. Baubac, has begun an exciting NEW hair growth therapy using Exosomes.
Exosomes are tiny balloons (known as “vesicles”) that cells send to each other to communicate. These communications are typically normal cell signals to the follicles, like “grow” or “divide” etc.. In the case of exosomes, Dr. Baubac injects a proprietary formulation into the thinning areas of the scalp for hair growth.
Our unique Exosome injections contain growth factors and cytokines much like the platelets in PRP/PPP but at a much more powerful and concentrated level. These tiny particles are collected from Stem Cells in a process that is FDA registered and inspected, and can be used for purposes ranging from healing and repair, to reducing inflammation, improving blood flow to follicles and stimulating new hair growth.
Dr. Baubac’s approach to Exosomes is to utilize Exosomes to stimulate hair growth and to reverse miniaturization of dormant hair by stimulating the DPCs and the HFSCs*. Dr. Baubac is an expert in the hair restoration field and oversees our Exosome growth factor injections.
Injections of Exosomes have been found to accelerate hair to return to the anagen phase or growing phase and support hair thickening as well as new growth. Our early results have been promising and are showing more potential than any other regenerative bicellular procedures available such as PRP or stem cell therapy.
Exosomes provide a potential solution to those patients who are looking for a non-surgical solution for their hair to add volume and density to their hair as well as regrow hair without the down time of a hair restoration procedure.
Dr. Baubac’s approach to Exosomes is to utilize Exosomes to stimulate hair growth and to reverse miniaturization of dormant hair by stimulating the DPCs and the HFSCs. Dr. Baubac is an expert in the hair restoration field and oversees our Exosome growth factor injections.
We apply Exosomes as a stand-alone treatment as well as in combination with our FUE hair transplant procedures. Not everyone is a candidate for Exosomes. Please discuss with your Alvi Armani Patient Consultant during your consultation if you would be a candidate for Exosome Therapy.
To be clear, we are NOT injecting stem cells, we are specifically injecting the particles that they create to communicate.
*Use of these Stem-cell derived vesicles to grow hair is new, and only very preliminary results are available, but some cases have been quite compelling. Patients report less shedding and increased growth in as little as 2 months with only a single treatment.
There are currently no approved products with exosomes. Just like there are no approved 361 HCT/P allograft cell or tissue products. HCT/Ps are registered with the FDA and do not require prior FDA approval so long as they are intended for homologous use, are minimally manipulated, and meet certain other regulatory criteria.
The most current guidance document for 361 HCT/Ps, “Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue Based Products: Minimal Manipulation and Homologous Use, Guidance for Industry and Food and Drug Administration Staff,” was issued in November 2017 (and was corrected in December 2017). This 2017 Guidance for HCT/Ps has not changed and has been referenced repeatedly in all subsequent letters or actions by the FDA.
If a patient has been told that a product can be used for the “treatment” of a disease, the FDA recommends that patients ask if the FDA has formally approved the product and/or to see an IND number associated with an FDAauthorized clinical trial of the product being studied for that treatment.
About Direct Biologics:
1. Direct Biologics processes all exosomes at a cGMP facility. This is the highest standard of processing and manufacturing controls.
2. Direct Biologics’ ExoFlo is marketed solely for homologous use. There are NO approved indications for the use of ExoFlo or XoFlo
3. Direct Biologics’ ExoFlo is a minimally-manipulated single-donor-per-lot tissue and contains no animal products, chemicals or drugs in the processing and isolation of the exosome products.
4. Direct Biologics is actively preparing to pursue FDA approval and will be submitting its first of several applications for IND clinical trials in various indications.