US businesses engaged in direct-to-consumer marketing of perinatal stem cell interventions following the Food and Drug Administration's enforcement discretion era.

BACKGROUND AIMS: The goal of this study was to analyze online marketing representations made by 300 US businesses selling allogeneic perinatal stem cell products. The study was conducted after a period of enforcement discretion by the US Food and Drug Administration (FDA). METHODS: Data mining and content analysis were used to identify, analyze and categorize marketing claims made on the websites of 300 businesses selling perinatal stem cell interventions. RESULTS: The study identified types of perinatal interventions companies advertised, geographic locations of clinics selling such products, types of companies operating in this space, diseases and injuries such businesses claim to treat, prices companies charge for such interventions, brand names of advertised perinatal cell products and identities of suppliers. CONCLUSIONS: A substantial number of US businesses market unapproved perinatal stem cell products for various indications. This widespread commercial activity occurred following the conclusion of a period of enforcement discretion by the FDA and suggests the need for more robust and comprehensive regulatory responses to businesses selling unapproved perinatal stem cell products.

Regulatory claims made by US businesses engaged in direct-to-consumer marketing of purported stem cell treatments and exosome therapies.

Aim: This study investigated whether US businesses engaged in direct-to-consumer online marketing of purported stem cell therapies and stem cell-derived exosome products made claims concerning the regulatory status of these interventions. Methods: We used data mining and content analysis of company websites to examine regulatory-related representations made by US businesses marketing stem cell treatments and exosome therapies. Results: More than two thirds of such businesses did not make explicit representations about the regulatory status of their marketed products. Businesses that made claims about the regulatory status of the stem cell and exosome products they sold used range of representations concerning the legal standing of these interventions. Conclusion: The absence of information addressing the regulatory status of stem cell interventions and exosome products and the use of what appeared to be inaccurate information concerning the regulatory status of numerous products likely complicates efforts by customers to make informed health-related decisions.

Businesses marketing purported stem cell treatments and exosome therapies for COVID-19: An analysis of direct-to-consumer online advertising claims.

We identified 38 businesses advertising purported stem cell interventions and exosome products for COVID-19. These companies operated or facilitated access to 60 clinics. More than 75% of these clinics were based in the United States and Mexico. Thirty-six of the businesses marketed their stem cell and exosome products as treatments for Long COVID, six advertised them as "immune boosters," five claimed to treat patients in the acute infection phase, and two claimed their products were preventive. The least expensive product cost $2,950, the most expensive was $25,000, and the average listed cost for patients was $11,322. The promotion of these products is concerning because they have not been approved by national regulators and do not appear to be supported by convincing safety and efficacy data.

Safety and efficacy claims made by US businesses marketing purported stem cell treatments and exosome therapies.

Aim: Examining websites of US businesses engaged in direct-to-consumer advertising of putative stem cell treatments and exosome therapies, this study investigated the marketing claims such companies make about the purported safety and efficacy of these products. Methods: Data mining and content analysis of company websites were used to identify and analyze safety and efficacy claims. Results: Of the 978 businesses analyzed, less than half the companies made identifiable claims about the safety and efficacy of their advertised stem cell and exosome products. We also explored how companies framed the stem cell and exosome products they promoted. Representations ranged from assertions that such products are unproven and investigational to claims they constituted cures. Most advertising frames fell between these poles. Conclusion: Some businesses include in their marketing representations claims about the safety and efficacy of advertised products. Businesses that did not make such assertions use other techniques to attract prospective clients.

Endophytic upper tract urothelial carcinoma in a solitary kidney treated by cryotherapy: an unorthodox case for successful management.

BACKGROUND: Nephroureterectomy remains the gold standard treatment for upper tract urothelial carcinoma (UTUC). Considering the high risk of developing renal function impairment after surgery, the rationale for nephron sparing approaches in treatment of UTUC has been raised. In this case, renal cryoablation was able to achieve successful oncologic control while preserving renal function during 5 years of follow up without intraoperative or post operative complications. CASE PRESENTATION: A 79 year old male presents after three months of macroscopic hematuria. Imaging revealed a 3.6 × 3.1 × 2.7 cm endophytic mass in the interpolar region of the left kidney and an atrophic right kidney. After weighing the lesion's location with the patient's of complex medical history, he was counselled to undergo a minimally invasive percutaneous cryoablation as treatment for his solitary renal mass. A diagnostic dilemma was encountered as imaging suggested a diagnosis of renal cell carcinoma. However, the pre-ablation biopsy established an alternative diagnosis, revealing UTUC. Percutaneous cryoablation became an unorthodox treatment modality for the endophytic component of his UTUC followed by retrograde ureteroscopic laser fulguration. The patient was followed in 3 months, 6 months, then annually with cross sectional imaging by MRI, cystoscopy, urine cytology and renal function testing. After five years of follow-up, the patient did not encountered recurrence of UTUC or deterioration in renal function, thereby maintaining a stable eGFR. CONCLUSION: Although evidence for nephron-sparing modalities for UTUC is mounting in recent literature, limited data still exists on cryotherapy as a line of treatment for urothelial carcinoma. We report successful management of a low-grade UTUC using cryoablation with the crucial aid of an initial renal biopsy and long-term follow-up. Our results provide insight into the role of cryoablation as a nephron-sparing approach for UTUC.

[Comparative study of clinical and pathological features of breast cancer in women with 40 years old and younger vs 70 years old and older]. / Comparación de las características de pacientes de 40 o menos y 70 años o más de edad con carcinoma mamario.

BACKGROUND: Invasive breast cancer is the most common neoplasia in women attended at IMSS health system since 2004. OBJECTIVE: To compare clinical and radiological characteristics on initial appraisal, as well as surgical treatment, pathological features and adjuvant treatment in women with primary breast cancer of 40 years old and younger vs 70 years old and older. MATERIAL AND METHOD: Clinical, radiological and pathological data of 150 patients with breast cancer treated at Hospital de ginecoobstetricia Luis Castelazo Ayala, from January 2003 to June 2006 were collected, and after divided in two groups: 1) patients with 40 years old and younger (n = 50), and 2) patients with 70 years old and older (n = 100). RESULTS: Tumoral size and radiological characteristics were similar in both groups. Group 1 and group 2 had 22 and 13%, respectively, of family history of breast cancer. Fine needle biopsy has positive predictive value of 50% for group 1, and 36% for group 2. Conservative surgery was less common at group 2. Most frequent histological type in both groups was infiltrating ductal carcinoma, followed by infiltrating lobular carcinoma, most common in older women (19 vs 12%), and we found more well differentiated ductal carcinomas in the group of 70 years old and older (12 vs 4%). Seventy-six percent of group 1 and 75% of group 2 were classified as early stage breast cancer (stages I and II). Cytotoxic therapy was offered mostly to group 1, 92 vs 35%. Radiotherapy (80 vs 59%), and hormonal therapy was given only to 56% of group 1 vs 80% of group 2. CONCLUSIONS: Clinical and staging features were similar in both groups. Family history was more influential to group 1. Fine needle biopsy has a low positive predictive value for diagnostic. Well-differentiated carcinomas were higher in patients of group 2, and group 1 had more high-grade carcinomas. There was a trend to perform more conservative surgery at group 1, as well as they underwent more adjuvant chemotherapy and radiotherapy. Use of hormonal therapy was more common at group 2.