Ex Vivo Study of hAMSC Secretome in Inflammatory Bowel Disease: Effects on Inflammation and Fibrosis (TARGET)
Not applicable · Testing Human amniotic mesenchymal stromal cell (hAMSC)-derived secretome · Sites not listed yet · Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Human amniotic mesenchymal stromal cell (hAMSC)-derived secretome (a biologic) to better understand how the disease works. Condition(s) listed: Inflammatory Bowel Diseases.
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- Age ≥ 18 years
- Confirmed diagnosis of inflammatory bowel disease (IBD), including Crohn's disease or ulcerative colitis
- Classification into one of the predefined clinical subgroups (remission, active treatment-naïve disease, refractory disease defined as failure of ≥2 lines of therapy, or fibrostenotic Crohn's disease phenotype)
Plus 2 more requirement(s). There are also 3 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 40 participants are expected to take part.
- Start date: 2026-11-01 (planned).
- Main results expected around 2027-11-01 (estimate from the record).
- No study sites are listed yet. Check the official record for contact details.
Main thing being measured
- Ex vivo modulation of immune cell populations by hAMSC-derived secretome (Ex vivo assessment performed within 7 days of sample collection.)
In the researchers’ words
Inflammatory Bowel Diseases (IBD), including ulcerative colitis and Crohn's disease, are chronic immune-mediated disorders characterized by relapsing gastrointestinal inflammation driven by genetic, immune, microbial, and environmental factors. Despite advances in biologic therapies and small molecules, a substantial proportion of patients exhibit incomplete response, loss of response over time, or progression…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Inflammatory Bowel Diseases |
| Lead sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Enrollment | 40 (estimated) |
| Start date | 2026-11-01 |
| Primary completion (est.) | 2027-11-01 |
| First posted | 2026-07-22 |
| Last updated | 2026-07-22 |
| Official title | Valutazione ex Vivo Del Secretoma di Cellule Stromali Mesenchimali Amniotiche Umane in Pazienti Con Malattie Infiammatorie Croniche Intestinali: Effetti su Infiammazione, Fibrosi e Riparazione Mucosale. |
| ClinicalTrials.gov ID | NCT07721207 |
Interventions
- Human amniotic mesenchymal stromal cell (hAMSC)-derived secretome (Biological)
Ex vivo exposure of patient-derived intestinal biopsies, peripheral blood mononuclear cells (PBMCs), and intestinal organoid co-culture systems to human amniotic mesenchymal stromal cell (hAMSC)-derived secretome. The secretome consists of bioactive soluble factors and extracellular vesicles evaluated for immunomodulatory, anti-inflammatory, anti-fibrotic, and pro-regenerative effects on immune, e…
Full eligibility criteria (from the record)
Inclusion Criteria: * Age ≥ 18 years * Confirmed diagnosis of inflammatory bowel disease (IBD), including Crohn's disease or ulcerative colitis * Classification into one of the predefined clinical subgroups (remission, active treatment-naïve disease, refractory disease defined as failure of ≥2 lines of therapy, or fibrostenotic Crohn's disease phenotype) * Availability of intestinal biopsies and/or peripheral blood mononuclear cells (PBMCs) for ex vivo analyses * Written informed consent for collection, storage, and use of biological samples for research purposes, in accordance with the Declaration of Helsinki and local Ethics Committee approval Exclusion Criteria: * Age < 18 years * Presence of systemic diseases not related to inflammatory bowel disease (IBD) that may interfere with immunological or molecular analyses * Inadequate or unavailable biological material for ex vivo experiments, including inability to generate patient-derived intestinal organoids
Locations (0)
No sites listed yet. The official record has contact information.
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.