Supreme Rejuvenation, LLC
FDA's Center for Biologics Evaluation and Research issued a warning letter to Supreme Rejuvenation, LLC (Houston, TX) in May 2025 for marketing human umbilical cord mesenchymal stem cell-derived exosome products without an approved biologics license application or investigational new drug application. The company's website and Instagram page made numerous disease-treatment and structure/function claims for conditions including traumatic brain injury, arthritis, fibromyalgia, COVID-19 long-haulers, dementia, and androgenetic alopecia. FDA characterized the products as unapproved new drugs under FD&C Act § 505(a) and unlicensed biological products under PHS Act § 351(a)(1), warning that failure to respond adequately may result in seizure and/or injunction.
Flagged claims (10)
In the field of aesthetics, the exosomes have been shown to improve skin texture, reduce wrinkles, and stimulate hair growth. In a study conducted by Dr. Berman, the exosomes were found to stimulate hair growth in patients with androgenetic alopecia.
Exosomes have an anti-inflammatory effect which is beneficial for wound and scar healing and treating conditions such as psoriasis, eczema, rosacea and acne.
In orthopedics, the exosomes have been shown to reduce inflammation and promote cartilage regeneration, making them effective in treating arthritis and other joint-related conditions. The exosomes have also been shown to improve outcomes in spinal cord injuries.
Regenerative medicine products are designed to target inflammation and repair damaged tissues. They are intended for use in studies related to hair growth and wound care to addressing Traumatic Brain Injury, joint and ligament repair, Botox alternatives, IV infusions, various other conditions.
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Furthermore, the exosomes have been shown to have neuro-protective effects and can promote nerve regeneration in conditions such as optic nerve damage and glaucoma. Studies have also shown that the exosomes can improve symptoms in patients with COVID-19 long-haulers and dementia.
Exosomes act as nature's messengers, facilitating intercellular communication. When they fuse with target cells, they deliver their payload, thereby kickstarting processes that promote tissue repair, regeneration, and growth.
Exosome therapy offers exciting possibilities for women's health! From reducing wrinkles, fine lines, and sagging skin to relieving menopausal symptoms like hot flashes and vaginal dryness, this innovative treatment can rejuvenate and restore balance… Discover how exosome therapy can help you feel your best-call us ... today.
A diabetic patient that does an Exosome IV injection has been known to decrease their dependency of Insulin injections as soon as two weeks.
Stem cell-derived exosomes have shown incredible efficacy in various studies, from peripheral nerve damage and traumatic brain injury to wound healing, bone fusion, and more. They possess anti-inflammatory properties and play vital roles in skin, cartilage, and bone regeneration, making them versatile assets in regenerative medicine.
Required actions (2)
Please submit your response in writing within fifteen (15) working days from your receipt of this letter, outlining the specific steps you have taken or plan to take to address any violations and prevent their recurrence.
Failure to adequately address these matters may result in action without further notice including, without limitation, seizure and/or injunction.
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