Health Condition 1: N359- Urethral stricture, unspecified
Conditions
Interventions
Intervention1: Autologous Adult Live Cultured Buccal Epithelial Cells (UregrowTM): Autologous Adult Live Cultured Buccal Epithelial Cells (UregrowTM) is performed cystoscopically.
Defect site is acces
Sponsors
Regrow Biosciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male subjects aged 18 to 65 years (both inclusive) with bulbar urethral stricture of at least 1 â?? 4 cm in length with or without prior visual internal urethrotomy (VIU). 2. Subjects with urethral stricture diagnosed by clinical symptoms and evaluation by Retrograde Urethrography (RUG). 3. Subject is willing and able to comply with follow-up and required clinic visit. 4. Body mass index (BMI) 5. Subjects (or legally acceptable representative [LAR] of impartial witness) who are able to provide written informed consent prior to participation in the study.
Exclusion criteria
Exclusion criteria: 1. Subject with bulbar urethral stricture less than 1 cm and more than 4 cm in length. 2. Subject with pan urethral stricture greater than 4 cm, completely obliterated stricture with insufficient urethral plate, and previously failed urethroplasty. 3. Subject with gonorrheal infection, enlarged prostate, hypospadias, phimosis or other malignancies of urethra. 4. Subject with history of steroid or other immunosuppressant treatment prior to 6 months. 5. Subjects with malignant tumors, who have undergone radiotherapy or chemotherapy within last 2 years. 6. Subjects who have history of hematological malignancies/ other malignancies. 7. Subjects who have hemoglobinopathies such as and not limited to sickle cell anemia, leukemia and thalassemia. 8. Subjects who have ongoing history of severe/critical cardiac, renal and hepatic dysfunctions and may be considered as per Investigatorâ??s discretion. 9. Subjects with type 1 or type 2 Diabetes Mellitus having pre-prandial blood glucose levels >130mg/dL and post prandial blood glucose levels >180 mg/dL at screening visit. Such subjects may be considered, as per Investigatorâ??s discretion if subject is under controlled blood glucose level. 10. Subjects with acute infections of mouth and urinary tract currently on treatment with antibiotics and antimicrobials will not be included. Such subjects may be considered after completion of adequate treatment and as per Investigatorâ??s discretion. 11. Subjects with psychiatric disorders who are considered inappropriate to participate in this study by the principal investigator. Subjects with psychiatric disorders who are on stable medication may be included in the study as per investigatorâ??s discretion. 12. History of receiving an investigational product within 30 days prior to enrollment in this study. 13. Subjects who are tested positive for HIV, Hepatitis B or Hepatitis C and Syphilis at the time of screening. 14. Subjects who are diagnosed with tuberculosis at the time of screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the safety of the Autologous Adult Live Cultured Buccal Epithelial Cells (UregrowTM) implantation for the treatment of urethral strictures.Timepoint: 7 Visits | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of Autologous Adult Live Cultured Buccal Epithelial Cells (UregrowTM) implantation for the treatment of urethral strictures.Timepoint: 7 visits | — |
Countries
India
Contacts
Public ContactNishith Sheth
Regrow Biosciences Pvt. Ltd
Outcome results
None listed