Trial reportWorld journal of urology2021
A prospective, multi-center, open-label, single-arm phase 2b study of autologous adult live cultured buccal epithelial cells (AALBEC) in the treatment of bulbar urethral stricture.
Trial report in World journal of urology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
6 citing papers in PubMed, 8 citations in OpenAlex.
- Imagining the future: the five "Laws" of endourethroplasty.International urology and nephrology · 2025Article
- Comparative efficacy of autologous adult live cultured buccal epithelial cells (AALBEC) and minced buccal mucosal graft endourethral urethroplasty (MBGEU) in male urethral stricture.International urology and nephrology · 2025Article
- BEES-HAUS preventing urethral stricture recurrence by restoring the integrity of urothelium and its further simplified version, the BHES-HAUS.Frontiers in bioengineering and biotechnology · 2025Article
- Cell-Based Therapy for Urethral Regeneration: A Narrative Review and Future Perspectives.Biomedicines · 2023Review
- Engraftment of Transplanted Buccal Epithelial Cells onto the Urethrotomy Site, Proven Immunohistochemically in Rabbit Model; a Feat to Prevent Urethral Stricture Recurrence.Stem cell reviews and reports · 2023Article
- Modification of minced buccal mucosal graft endourethral urethroplasty: A pilot study.Indian journal of urology : IJU : journal of the Urological Society of IndiaArticle
Corrections and comments
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Authors and funding
4 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTo evaluate the safety and efficacy of autologous adult live cultured buccal epithelial cells (AALBEC) in treatment and management of bulbar urethral stricture in men.
methodsThis was a prospective, multi-center, open-label, single-arm phase 2b study. A total of 18 male patients with bulbar urethral stricture of at least 1 - 4 cm in length were enrolled in the study. All 16 patients had AALBEC implanted and were included in the safety set. Change in total American Urology Association (AUA) symptom score, urinary flow rates assessed by uroflowmetry and a requirement for surgery after 24 weeks from baseline were determined in patients. Data of treatment efficacy were analyzed.
resultsThe AUA score at baseline was 21 (3.9) that showed a statistically significant reduction starting from week 2 [8 (4.4), p = 0.0001] which sustained until week 24 [2 (1.2), p = 0.0005]. Overall mean total AUA symptom score was reduced by 90.5% after the treatment. Significant reductions from baseline at week-24 were also observed in voiding time (92.5 (47.3) vs. 51.9 (17.4) s, p = 0.0046) and flow time [86.9 (48.2) vs. 47.9 (19.6) s, p = 0.0052]. All patients showed absence of any significant adverse events.
conclusionSignificant improvement was seen in the AUA symptom score and uroflowmetry parameters and no patients required surgery during 24 weeks post-treatment. It can be concluded that AALBEC is a safe and effective treatment for bulbar urethral stricture of 1 - 4 cm length to improve the quality of life and the physiological function of urethra.
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