An observational study in Interstitial Cystitis/Painful Bladder Syndrome, sponsored by University of Roma La Sapienza. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-05.
Sponsored by University of Roma La Sapienza · Observational
Interstitial cystitis (IC) is a chronic, urological condition characterized by bladder pain, and persistent urinary symptoms. Its complex pathophysiology involves autoimmune mechanisms, urothelial barrier dysfunctions, alterations in sensory neural pathways, and degradation of connective tissue. Epidemiological data show a significant prevalence, often affecting adults of working age and disproportionately impacting women, with a major effect on quality of life. Conventional treatments-including behavioral modifications, pharmacotherapy, and invasive procedures-frequently fail to provide lasting relief, underscoring the need for alternative therapeutic strategies. Regenerative medicine has emerged as a promising field capable of targeting the underlying pathophysiology of chronic diseases. Among its tools, mesenchymal stromal cells (MSCs) derived from adipose tissue are of particular interest due to their availability, regenerative potential, and immunomodulatory properties. Through paracrine signaling, secretion of trophic factors, soluble mediators, and exosomes, MSCs may support tissue repair and reduce inflammation. Micronized adipose tissue (MAT), obtained through minimal manipulation using intraoperative techniques, provides a scaffold-rich environment that preserves stromal cell integrity and enhances therapeutic potential. The Matrigen device allows the processing of autologous fat into MAT that meets the European Regulation (EC) No. 1394/2007 criteria for "non-substantial manipulation." Preclinical and early clinical studies have highlighted the potential of adipose-derived MSCs in treating IC/bladder pain syndrome (Wen et al., 2021; Dayem et al., 2022) and urinary incontinence (Garcia-Arranz et al., 2019), showing both regenerative and anti-inflammatory effects.
The study aims to retrospectively evaluate the safety and effectiveness of micronized adipose tissue obtained with the Matrigen device in improving symptoms and urodynamic outcomes in patients previously treated for interstitial cystitis.
This retrospective observational cohort study involves 20 patients diagnosed with interstitial cystitis, treated between April and October 2024 with intraoperative infiltration of micronized adipose tissue obtained using the Matrigen system. Clinical, procedural, and follow-up data were collected from electronic medical records and anonymized prior to analysis.
Primary Endpoints:
Secondary Endpoints:
Lipoaspiration and MAT Preparation During the same surgical session, subcutaneous adipose tissue (approximately 50 mL) was harvested from the abdominal or proximal thigh regions under local anesthesia (500 mL saline + 2 vials of 2% Marcaine or Lidocaine + 1 vial of epinephrine 1 mg/mL). Harvesting was performed with a 13G cannula connected to a syringe to minimize cellular damage. The lipoaspirate was processed using the Matrigen device according to manufacturer instructions to obtain micronized adipose tissue (MAT).
MAT Injection: The prepared MAT was injected into the bladder wall under direct visualization using a 5 Fr injection needle during urethrocystoscopy. The bladder was divided into four quadrants, with 5-6 injections per quadrant (0.2-0.3 mL each) placed 0.5 mm submucosally to ensure even distribution.
In patients with Hunner lesions, injections were targeted circumferentially around each lesion, spaced at least 1 cm apart, using the same volume and depth to optimize local regenerative effects.
Ethical Considerations This study was conducted in accordance with the Declaration of Helsinki and relevant ethical standards.
Endpoints Primary Endpoints
Inclusion Criteria
Exclusion Criteria
Clinical Procedures 7.1 Lipoaspiration and MAT Preparation During the same surgical session, subcutaneous adipose tissue (approximately 50 mL) was harvested from the abdominal or proximal thigh regions under local anesthesia (500 mL saline + 2 vials of 2% Marcaine or Lidocaine + 1 vial of epinephrine 1 mg/mL). Harvesting was performed with a 13G cannula connected to a syringe to minimize cellular damage. The lipoaspirate was processed using the Matrigen device according to manufacturer instructions to obtain micronized adipose tissue (MAT).
7.2 MAT Injection The prepared MAT was injected into the bladder wall under direct visualization using a 5 Fr injection needle during urethrocystoscopy. The bladder was divided into four quadrants, with 5-6 injections per quadrant (0.2-0.3 mL each) placed 0.5 mm submucosally to ensure even distribution.
In patients with Hunner lesions, injections were targeted circumferentially around each lesion, spaced at least 1 cm apart, using the same volume and depth to optimize local regenerative effects.
220 studies on the registry are indexed under Cystitis, Interstitial; 33 are open to participants now.
This study's enrollment of 20 is below the median of 91 across 57 observational studies indexed under Cystitis, Interstitial.
Browse Cystitis, Interstitial studies →University of Roma La Sapienza is the lead sponsor of 388 studies on the registry; 55 are open to participants now.
Counted across the registry records on this site, refreshed daily.
20 adult patients diagnosed with interstitial cystitis non responders to standard medical oral therapies
Exclusion Criteria:
Procedure: Mesenchymal Stem Cell Transplantation
intraoperative infiltration of micronized adipose tissue obtained using the Matrigen system.
Efficacy and Safety of MSC in IC
Visual Analogic Scale (minimum 0 - maximum 10, where 0 means best outcome and 10 worse outcome)
Time frame: 0,1,3 and 6 months
Efficacy and Safety of MSC in IC
Short Form Healthy Survey 36 (minimum 0 - maximum, where 0 means the worse outcome and 100 the best outcome)
Time frame: 0, 1, 3 and 6 months
Efficacy and Safety of MSC in IC
O' Leary Interstitial Cystitis Symptoms/Problems Index (minimum 0 - maximum 36, where 0 means best outcome and 36 worse outcome)
Time frame: 0, 1, 3 and 6 months
Efficacy and Safety of MSC in IC
Medical Outcomes Study Sexual Functioning Scale (minimum 0 - maximum 16, where 0 means best outcomes and 16 worse outcome)
Time frame: 0, 1, 3 and 6 months
Efficacy and Safety of MSC in IC
Urethrocystoscopy (description of lesions evaluated by the performer with a scale that is ranged from 0 t0 5: 0 means normal bladder mucosa, and 5 means Hunner lesions with ongoing bleeding)
Time frame: 0,1,3 and 6 months
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Institution Privacy Policy
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Roma La Sapienza