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Interstitial Cystitis/Painful Bladder SyndromeIC_&_MAT_MSCsNCT07104981

Retrospective Results of Micronized Adipose Tissue in Patients With Interstitial Cystitis

An observational study of Interstitial Cystitis/Painful Bladder Syndrome, run by University of Roma La Sapienza at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Mesenchymal Stem Cell Transplantation
Type of treatment
Surgery or procedure
How many people
20 participants
Where
1 siteItaly
Study dates
4 Apr 2024to 4 Apr 2025
How long will I take part?
12 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • ICOT Hospital, Via Franco Faggiana 1668, 04100 Latina

    Latina, 04100

Other trials in Italy

About this study

Official title: Retrospective Evaluation of the Efficacy and Safety of Micronized Adipose Tissue Obtained With the Matrigen Device in the Treatment of Patients With Interstitial Cystitis

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.

Read more

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
  1. 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
  1. 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
  1. 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.
  2. 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.
Being tested
Mesenchymal Stem Cell Transplantation
Keywords
Interstitial Cystitis, Mesenchimal stem cells, Micronized adipose tissue
Medical subject headings
Cystitis, Interstitial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mesenchymal Stem Cell TransplantationProcedure or surgery

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

Study groups in NCT07104981
Study groupRoleWhat they receive
20 patients with Interstitial CystitisNot described
Receives: Procedure: Mesenchymal Stem Cell Transplantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy and Safety of MSC in IC

    Visual Analogic Scale (minimum 0 - maximum 10, where 0 means best outcome and 10 worse outcome)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 0,1,3 and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2025
  2. Study start4 Apr 2024
  3. Primary completion8 Oct 2024
  4. Study completion4 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
20 participants (actual)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07104981
Sponsor's protocol ID
NANOFATUROGYN
Other IDs
UNIVLTURO2024_ICMATMSCs
Acronym
IC_&_MAT_MSCs
Status last verified
Aug 2025
First submitted
11 Jun 2025
Last updated
5 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Institution Privacy Policy

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

Questions about this trial

What is this clinical trial studying?

An observational study of Interstitial Cystitis/Painful Bladder Syndrome, run by University of Roma La Sapienza at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy and Safety of MSC in IC (time frame: 0,1,3 and 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07104981, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.

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