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CompletedNCT07104981IC_&_MAT_MSCsUpdated Aug 5, 2025

Retrospective Results of Micronized Adipose Tissue in Patients With Interstitial Cystitis

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

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
20
Ages
18 Years and older
Sex
All
01

Study summary

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:

  • Urodynamic testing results at baseline and 6 months post-treatment
  • Cystoscopic findings at baseline and 6 months post-treatment

Secondary Endpoints:

  • Patient-reported pain and symptom scores using VAS, GLOBE SF-36, O'Leary IC Symptom/Problem Index, and MOS Sexual Functioning Scale at baseline and 1, 2, and 3 months post-treatment
  • Physical examination at baseline and 3 months post-treatment
  • Evaluation of bladder capacity, detrusor pressure, compliance, urinary flow, and post-void residual volume at baseline and 6 months
  • Cystoscopic evaluation of mucosal condition and lesion status at baseline and 6 months Inclusion Criteria
  • Adult patients (≥18 years) diagnosed with interstitial cystitis
  • History of treatment with micronized adipose tissue using the Matrigen device
  • Complete clinical documentation, including surgical and follow-up data
  • Informed consent previously obtained for data use in clinical research Exclusion Criteria
  • Active urinary tract infections at time of treatment
  • Corticosteroid therapy within 3 months prior to the intervention
  • History of tuberculosis, malignancy, or severe systemic disease
  • Pregnancy or lactation at the time of the procedure

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.

Read the detailed description
  1. Introduction and Rationale Interstitial cystitis (IC) is a chronic, multifactorial urological condition characterized by bladder pain, pressure, and persistent urinary symptoms. Its complex and not yet fully understood pathophysiology involves autoimmune mechanisms, dysfunction of the urothelial barrier, alterations in sensory neural pathways, muscle abnormalities, and degradation of subepithelial 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.
  2. Objective 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.
  3. Study Design This is a retrospective observational cohort study involving 20 adult patients diagnosed with interstitial cystitis, treated between 04 April and 08 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.
  4. Endpoints Primary Endpoints

    • Urodynamic testing results at baseline and 6 months post-treatment
    • Cystoscopic findings at baseline and 6 months post-treatment Secondary Endpoints
    • Patient-reported pain and symptom scores using VAS, GLOBE SF-36, O'Leary IC Symptom/Problem Index, and MOS Sexual Functioning Scale at baseline and 1, 2, and 3 months post-treatment
    • Physical examination at baseline and 3 months post-treatment
    • Evaluation of bladder capacity, detrusor pressure, compliance, urinary flow, and post-void residual volume at baseline and 6 months
    • Cystoscopic evaluation of mucosal condition and lesion status at baseline and 6 months
  5. Inclusion Criteria

    • Adult patients (≥18 years) diagnosed with interstitial cystitis
    • History of treatment with micronized adipose tissue using the Matrigen device
    • Complete clinical documentation, including surgical and follow-up data
    • Informed consent previously obtained for data use in clinical research
  6. Exclusion Criteria

    • Active urinary tract infections at time of treatment
    • Corticosteroid therapy within 3 months prior to the intervention
    • History of tuberculosis, malignancy, or severe systemic disease
    • Pregnancy or lactation at the time of the procedure
  7. 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.

  8. Ethical Considerations This study was conducted in accordance with the Declaration of Helsinki and relevant ethical standards. Institutional review board (IRB) approval was obtained. All patients had previously provided informed consent for clinical data use.
02

Conditions studied

  • Interstitial Cystitis/Painful Bladder Syndrome

Keywords

  • Interstitial Cystitis
  • Mesenchimal stem cells
  • Micronized adipose tissue
03

In context

Cystitis, Interstitial

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

20 adult patients diagnosed with interstitial cystitis non responders to standard medical oral therapies

Inclusion criteria

  • Adult patients (≥18 years) diagnosed with interstitial cystitis
  • History of treatment with micronized adipose tissue using the Matrigen device
  • Complete clinical documentation, including surgical and follow-up data
  • Informed consent previously obtained for data use in clinical research

Exclusion criteria

Exclusion Criteria:

  • Active urinary tract infections at time of treatment
  • Corticosteroid therapy within 3 months prior to the intervention
  • History of tuberculosis, malignancy, or severe systemic disease
  • Pregnancy or lactation at the time of the procedure
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
20 participants (actual)
Target follow-up
12 Months
Patient registry
Yes

Groups and cohorts

  • 20 patients with Interstitial Cystitis

    Procedure: Mesenchymal Stem Cell Transplantation

Interventions

  • ProcedureMesenchymal Stem Cell Transplantation

    intraoperative infiltration of micronized adipose tissue obtained using the Matrigen system.

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

07

Study locations

1 site
  • ICOT Hospital, Via Franco Faggiana 1668, 04100 Latina
    Latina, 04100, Italy
08

References and documents

Publications

  • Wen C, Xie L, Hu C. Roles of mesenchymal stem cells and exosomes in interstitial cystitis/bladder pain syndrome. J Cell Mol Med. 2022 Feb;26(3):624-635. doi: 10.1111/jcmm.17132. Epub 2021 Dec 24. PubMed 34953040 ↗
  • Garcia-Arranz M, Alonso-Gregorio S, Fontana-Portella P, Bravo E, Diez Sebastian J, Fernandez-Santos ME, Garcia-Olmo D. Two phase I/II clinical trials for the treatment of urinary incontinence with autologous mesenchymal stem cells. Stem Cells Transl Med. 2020 Dec;9(12):1500-1508. doi: 10.1002/sctm.19-0431. Epub 2020 Aug 31. PubMed 32864818 ↗
  • Dayem AA, Song K, Lee S, Kim A, Cho SG. New therapeutic approach with extracellular vesicles from stem cells for interstitial cystitis/bladder pain syndrome. BMB Rep. 2022 May;55(5):205-212. doi: 10.5483/BMBRep.2022.55.5.035. PubMed 35410640 ↗

Study documents

  • Study protocol · Apr 4, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — Institution Privacy Policy

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07104981
Lead sponsor
University of Roma La Sapienza
Responsible party
Antonio Luigi Pastore (Associate Professor, MD, PhD, University of Roma La Sapienza) — Principal investigator
First posted
Aug 5, 2025
Start date
Apr 4, 2024
Primary completion
Oct 8, 2024
Completion
Apr 4, 2025
Last update
Aug 5, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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