Stem Cell Therapies
Stem Cell Therapies
Stem cell therapies
At Drozone Body Clinic, our focus is on delivering certified human mesenchymal stem cells sourced exclusively from Wharton Jelly (found in umbilical cord tissue) and placenta, both obtained from live, healthy births. We maintain a fully licensed laboratory authorized by COFEPRIS, Mexico’s equivalent of the FDA, enabling us to not only produce and store stem cells in a cryo-bank but also practice regenerative medicine. These licenses, all of which are provided below, underscore our commitment to upholding the highest standards throughout the collection, expansion, and application of mesenchymal stem cells. This rigorous approach ensures that the end product is entirely pathogen-free and of exceptional quality.
Our quality control procedures adhere strictly to good manufacturing practices, as well as the guidelines set forth by esteemed organizations such as the International Society of Cell Therapy and the Latin American Mesenchymal Stem Cell Society, of which we are proud members. To achieve this, we employ a xeno-free culturing medium during the expansion process, enabling us to achieve a third round of expansion. Our laboratory has achieved the ISO 7 qualification for Cleanroom status, attesting to our compliance with essential standards for producing injectable products.
The laboratory boasts specialized equipment, including Nuaire brand incubators and laminar flow hoods, both pivotal in ensuring the complete safety and harmlessness of our cellular products. The stem cells themselves originate from Wharton Jelly (Umbilical Tissue) and Placenta tissue, procured exclusively from rigorously screened donors. These donors undergo comprehensive medical assessments encompassing their complete clinical history, along with serologic tests for diseases such as HIV, Hepatitis C and B, syphilis, and Chagas, all adhering to meticulous inclusion criteria that render them eligible candidates for donation.
The laboratory boasts specialized equipment, including Nuaire brand incubators and laminar flow hoods, both pivotal in ensuring the complete safety and harmlessness of our cellular products. The stem cells themselves originate from Wharton Jelly (Umbilical Tissue) and Placenta tissue, procured exclusively from rigorously screened donors. These donors undergo comprehensive medical assessments encompassing their complete clinical history, along with serologic tests for diseases such as HIV, Hepatitis C and B, syphilis, and Chagas, all adhering to meticulous inclusion criteria that render them eligible candidates for donation.
Upon extraction, the obtained samples undergo a battery of evaluations conducted by third-party laboratories authorized by COFEPRIS. These evaluations encompass flow cytometry as well as microbiological assessments for mycoplasma and endotoxins. An additional facet of our certified stem cell procurement process involves a policy to exclude Wharton Jelly or Placenta tissue from donors who have received the Covid Vaccine. This decision stems from our belief that further study is necessary concerning the implications of the MRNA in the vaccine on the donated tissue from vaccinated mothers.”