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FDA Approves Clinical Trial for Phase II Stem Cell Research
The US Food and Drug Administration (FDA) gave approval to Indiana based clinical research company, Antria to conduct phase II trials in medical research to help patients undergo cosmetic surgery using their own stem cells.
According to Dr. Leonard Maliver CEO & founder of Antria, this is the first company to get FDA approval for second phase of clinical trials using autologous (self) adipose-derived stem cells (ADSC) for plastic surgery.
Stem cells are capable of self renewal through cell division and differentiate into any type of body cell. They have the potential to either remain as stem cells or become more specialized cells like blood cells, muscle cells, neural cells etc. Stem cells are found in various sources such as blood, bone marrow, cord tissue, skeletal muscles, skin, fat tissue, teeth, gut, liver, ovaries, testes etc. In this trial, Maliver and team used fat derived stem cells to treat arthritis, facial improvement, breast augmentation and reconstruction.
In this trial, they use liposuction to extract the patient’s fat tissue from thigh, belly and hip regions. Within one hour, the stem cells are isolated from the tissue and injected under the patient’s facial skin which will reduce wrinkles, scars and sagging skin. The same procedure can be used to treat arthritis where the stem cells tend to become cartilage cells when injected into the joints of the patients. Antria plans to implement the procedure in women for breast reconstruction after a breast cancer surgery. “It is all done in the operating room at the same time as the cosmetic surgical procedure… Essentially there were no undue adverse effects and everyone did well cosmetically and physiologically”, Maliver said.
The phase I research included 6 patients and got completed last year. The FDA monitored the outcomes of the trial and approved Phase II trials. The second phase is expected to have 34 patients and may take 2 years to complete. Assuming the study is successful and shows positive outcomes, FDA may grant clearance to sell the product commercially in USA.