Abstract Pelvic radiotherapy can lead to loss of bladder compliance, detrusor overactivity, and superficial vascular proliferation. Animal studies have demonstrated a reduction in radiation-induced inflammation and fibrosis following administration of mesenchymal stem cell products. We performed a first-in-human pilot study to assess the safety and feasibility of intravesical adipose stromal vascular fraction injection in an 82-year-old man with a history of brachytherapy for prostate cancer. Following FDA and IRB approval, subcutaneous adipose tissue harvested under local anesthesia was immediately processed using the SVF-2 device (GID Bio). The cell product, consisting of 4.58 × 107 stromal vascular fraction cells resuspended in 20 cc/s of lactated ringers, was injected into the bladder wall using a flexible cystoscope. Urinary symptoms, urologic flow parameters, repeat cystoscopy with bladder biopsy, and MRI were employed during the 16-month follow-up period. There were no postprocedural complications. The patient reported expected symptoms of self-limited dysuria, hematuria, and flank bruising in the 2 weeks following the procedure. Urinary symptoms and flow parameters remained stable for 6 months but progressed slightly at 15 months. A repeat cystoscopy with biopsy showed stabilization of disease without concern for secondary malignancy. The patient’s 12-month postprocedural MRI and 15-month urodynamics study were unchanged from prior. This study demonstrates the safety and feasibility of adipose harvest under local anesthesia, followed by point-of-care isolation and administration of an adipose-derived cell product via cystoscopic-guided intravesical injection. This pilot is foundational for further clinical studies to elucidate effective dosing and patient selection in the treatment of bladder fibrosis with cell therapy.
Klein et al. (2026) studied this question.