Inflammatory Bowel DiseasesTARGETNCT07721207
Ex Vivo Study of hAMSC Secretome in Inflammatory Bowel Disease: Effects on Inflammation and Fibrosis (TARGET)
A study testing Human amniotic mesenchymal stromal cell (hAMSC)-derived secretome in people with Inflammatory Bowel Diseases, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Human amniotic mesenchymal stromal cell (hAMSC)-derived secretome
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
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 toward structural bowel damage, including fibrosis, for which no approved anti-fibrotic therapies are currently available.
Current treatments mainly target single inflammatory pathways and are insufficient to restore the complex immune, epithelial, and stromal network dysfunction underlying disease persistence and progression, particularly in refractory disease and fibrostenotic Crohn's disease.
Read more
This study investigates the ex vivo effects of human amniotic mesenchymal stromal cell (hAMSC)-derived secretome, a cell-free biologic product containing bioactive mediators and extracellular vesicles with immunomodulatory, anti-inflammatory, anti-fibrotic, and pro-regenerative properties. The secretome is hypothesized to modulate immune responses, epithelial barrier integrity, mucosal repair, and fibrotic pathways simultaneously.
Preliminary data in peripheral blood mononuclear cells (PBMCs) show reduced T helper 1 (Th1) polarization with decreased interferon gamma (IFN-γ) and tumor necrosis factor alpha (TNF-α), and increased regulatory T cells (FOXP3+). Ex vivo experiments in Crohn's disease biopsies indicate a shift toward a more tolerogenic and reparative cytokine profile.
This monocentric translational study includes 40 adult patients (≥18 years) with confirmed IBD, stratified into four clinical subgroups based on disease activity, treatment exposure, and fibrostenotic phenotype. Intestinal biopsies and PBMCs are collected prospectively and analyzed within 7 days of sampling.
The primary objective is to evaluate ex vivo modulation of inflammatory, immune, epithelial, and fibrotic pathways after exposure to hAMSC secretome. Secondary objectives include assessment of fibrosis markers (COL1A1, ACTA2), epithelial barrier proteins (claudin-1, claudin-2, MUC2), barrier function (TEER), and molecular pathway changes using patient-derived organoids and co-culture systems under basal and pro-fibrotic conditions.
The study duration is 36 months, including sample collection, laboratory experiments, multi-omics analyses, and data integration.
Read the detailed description
This is a monocentric, translational, procedure-based interventional study investigating the ex vivo effects of human amniotic mesenchymal stromal cell (hAMSC)-derived secretome in inflammatory bowel diseases (IBD), including ulcerative colitis and Crohn's disease. The study is designed to evaluate the immunomodulatory, anti-inflammatory, anti-fibrotic, and pro-regenerative properties of a cell-free biologic product on patient-derived biological systems.
A total of 40 adult patients (≥18 years) with confirmed IBD are prospectively enrolled and stratified into four clinical subgroups based on disease activity, treatment exposure, and fibrostenotic phenotype. Intestinal biopsies (ileal and/or colonic) and peripheral blood mononuclear cells (PBMCs) are collected and processed within 7 days of sampling.
Patient-derived biological samples are exposed ex vivo to hAMSC-derived secretome, which contains soluble bioactive factors and extracellular vesicles. Experimental platforms include intestinal tissue explants, PBMC cultures, intestinal organoids, and PBMC-organoid co-culture systems. Organoids are derived from Crohn's disease biopsies and cultured under basal conditions and under transforming growth factor beta 1 (TGF-β1)-induced pro-fibrotic conditions to model disease-relevant microenvironments.
Immunological effects are assessed by multicolor flow cytometry, including characterization of T helper 1 (Th1), T helper 17 (Th17), regulatory T cells (Treg), macrophages, dendritic cells, and innate lymphoid cells. Cytokine profiling is performed using multiplex bead-based assays to quantify pro- and anti-inflammatory mediators, including tumor necrosis factor alpha (TNF-α), interferon gamma (IFN-γ), interleukin 6 (IL-6), interleukin 10 (IL-10), and interleukin 17 (IL-17).
Fibrotic remodeling is evaluated through analysis of collagen type I alpha 1 chain (COL1A1) and actin alpha 2 smooth muscle (ACTA2) expression using quantitative real-time polymerase chain reaction (RT-qPCR) and immunofluorescence. Epithelial barrier integrity is assessed by quantification of claudin-1, claudin-2, and mucin 2 (MUC2) expression, as well as functional measurement of transepithelial electrical resistance (TEER) in organoid-based systems.
Advanced multi-omics analyses are performed to characterize the immune-epithelial-stromal niche. Spatial transcriptomics (10x Genomics Visium) is used to map tissue-level transcriptional changes, integrated with single-cell RNA sequencing data to identify cell-type-specific responses and molecular pathways associated with treatment exposure. Bioinformatic analyses are conducted to define differentially regulated pathways and candidate biomarkers of response, with particular focus on refractory disease and fibrostenotic Crohn's disease phenotypes.
The study duration is 36 months, including patient recruitment and sample collection (months 4-18), ex vivo experimental procedures (months 6-20), multi-omics analyses (months 18-30), and data integration, interpretation, and dissemination (months 30-36).
Statistical analyses include assessment of normality using the Shapiro-Wilk test and homogeneity of variance using the Levene test. Group comparisons are performed using Student's t-test or Mann-Whitney U test for pairwise analyses, and one-way or two-way analysis of variance (ANOVA) with appropriate post hoc corrections (Bonferroni or Tukey). Non-parametric alternatives (Kruskal-Wallis test) are applied where appropriate. Statistical significance is defined as p < 0.05 (two-sided). Data analysis is performed using GraphPad Prism and R-based computational pipelines for high-dimensional biological data.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Human amniotic mesenchymal stromal cell (hAMSC)-derived secretome
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human amniotic mesenchymal stromal cell (hAMSC)-derived secretomeBiological
Also called amniotic MSC secretome, mesenchymal stromal cell secretome, conditioned medium hAMSC, extracellular vesicles hAMSC
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, epithelial, and stromal pathways.
| Study group | Role | What they receive |
|---|---|---|
| hAMSC secretome-treated samples | Other | Ex vivo treatment of patient-derived intestinal biopsies, peripheral blood mononuclear cells (PBMCs), and organoid co-culture systems with human amniotic mesenchymal stromal cell (hAMSC)-derived secretome. Receives: Biological: Human amniotic mesenchymal stromal cell (hAMSC)-derived secretome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ex vivo modulation of immune cell populations by hAMSC-derived secretome
Frequency and activation status of T helper 1 (Th1), T helper 17 (Th17), regulatory T cells (Treg), and innate immune populations in patient-derived intestinal biopsies and peripheral blood mononuclear cells (PBMCs) after ex vivo exposure to hAMSC-derived secretome, assessed by multicolor flow cytometry.
Measured: Ex vivo assessment performed within 7 days of sample collection.
Ex vivo modulation of inflammatory cytokines by hAMSC-derived secretome
Levels of key inflammatory and regulatory cytokines, including tumor necrosis factor alpha (TNF-α), interferon gamma (IFN-γ), interleukin 6 (IL-6), and interleukin 10 (IL-10), in supernatants of patient-derived intestinal biopsies and PBMCs after ex vivo exposure to hAMSC-derived secretome, assessed by multiplex cytokine assays.
Measured: Ex vivo assessment performed within 7 days of sample collection.
Ex vivo modulation of fibrosis- and mucosal repair-related markers by hAMSC-derived secretome.
Molecular analysis of fibrosis- and mucosal repair-related markers expression in patient-derived intestinal biopsies and PBMCs after ex vivo exposure to hAMSC-derived secretome.
Measured: Ex vivo assessment performed within 7 days of sample collection.
Secondary outcomes (3)
Intestinal epithelial barrier integrity and function
Evaluation of epithelial barrier markers including claudin-1, claudin-2, and mucin 2 (MUC2), and functional barrier assessment using transepithelial electrical resistance (TEER) measurements in organoid and PBMC co-culture systems.
Measured: Ex vivo analysis within 7 days of treatment
Transcriptomic and spatial omics profiling of immune-epithelial-fibrotic niche
Identification of transcriptional changes and signaling pathways in patient-derived tissues and organoids using spatial transcriptomics (10x Genomics Visium) and single-cell RNA sequencing integration to characterize molecular signatures associated with response to hAMSC secretome.
Measured: Within study period (months 6-30)
Immune-epithelial cross-talk modulation
Evaluation of interactions between immune cells and intestinal epithelial organoids in co-culture systems under basal and transforming growth factor beta 1 (TGF-β1)-induced pro-fibrotic conditions following exposure to hAMSC secretome.
Measured: Ex vivo analysis within 7 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Ex vivo translational study using patient-derived intestinal biopsies, peripheral blood mononuclear cells, and organoid co-culture systems treated with human amniotic mesenchymal stromal cell (hAMSC)-derived secretome.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07721207
- Sponsor's protocol ID
- TARGET 27622
- Acronym
- TARGET
- Status last verified
- Jul 2026
- First submitted
- 1 Jul 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- TARGET / TARGET 27622
- Conditions
- Inflammatory Bowel Diseases
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 toward structural bowel damage, including fibrosis, for which no approved anti-fibrotic therapies are currently available.
Current treatments mainly target single inflammatory pathways and are insufficient to restore the complex immune, epithelial, and stromal network dysfunction underlying disease persistence and progression, particularly in refractory disease and fibrostenotic Crohn's disease.
This study investigates the ex vivo effects of human amniotic mesenchymal stromal cell (hAMSC)-derived secretome, a cell-free biologic product containing bioactive mediators and extracellular vesicles with immunomodulatory, anti-inflammatory, anti-fibrotic, and pro-regenerative properties. The secretome is hypothesized to modulate immune responses, epithelial barrier integrity, mucosal repair, and fibrotic pathways simultaneously.
Preliminary data in peripheral blood mononuclear cells (PBMCs) show reduced T helper 1 (Th1) polarization with decreased interferon gamma (IFN-γ) and tumor necrosis factor alpha (TNF-α), and increased regulatory T cells (FOXP3+). Ex vivo experiments in Crohn's disease biopsies indicate a shift toward a more tolerogenic and reparative cytokine profile.
This monocentric translational study includes 40 adult patients (≥18 years) with confirmed IBD, stratified into four clinical subgroups based on disease activity, treatment exposure, and fibrostenotic phenotype. Intestinal biopsies and PBMCs are collected prospectively and analyzed within 7 days of sampling.
The primary objective is to evaluate ex vivo modulation of inflammatory, immune, epithelial, and fibrotic pathways after exposure to hAMSC secretome. Secondary objectives include assessment of fibrosis markers (COL1A1, ACTA2), epithelial barrier proteins (claudin-1, claudin-2, MUC2), barrier function (TEER), and molecular pathway changes using patient-derived organoids and co-culture systems under basal and pro-fibrotic conditions.
The study duration is 36 months, including sample collection, laboratory experiments, multi-omics analyses, and data integration.
Detailed description
This is a monocentric, translational, procedure-based interventional study investigating the ex vivo effects of human amniotic mesenchymal stromal cell (hAMSC)-derived secretome in inflammatory bowel diseases (IBD), including ulcerative colitis and Crohn's disease. The study is designed to evaluate the immunomodulatory, anti-inflammatory, anti-fibrotic, and pro-regenerative properties of a cell-free biologic product on patient-derived biological systems.
A total of 40 adult patients (≥18 years) with confirmed IBD are prospectively enrolled and stratified into four clinical subgroups based on disease activity, treatment exposure, and fibrostenotic phenotype. Intestinal biopsies (ileal and/or colonic) and peripheral blood mononuclear cells (PBMCs) are collected and processed within 7 days of sampling.
Patient-derived biological samples are exposed ex vivo to hAMSC-derived secretome, which contains soluble bioactive factors and extracellular vesicles. Experimental platforms include intestinal tissue explants, PBMC cultures, intestinal organoids, and PBMC-organoid co-culture systems. Organoids are derived from Crohn's disease biopsies and cultured under basal conditions and under transforming growth factor beta 1 (TGF-β1)-induced pro-fibrotic conditions to model disease-relevant microenvironments.
Immunological effects are assessed by multicolor flow cytometry, including characterization of T helper 1 (Th1), T helper 17 (Th17), regulatory T cells (Treg), macrophages, dendritic cells, and innate lymphoid cells. Cytokine profiling is performed using multiplex bead-based assays to quantify pro- and anti-inflammatory mediators, including tumor necrosis factor alpha (TNF-α), interferon gamma (IFN-γ), interleukin 6 (IL-6), interleukin 10 (IL-10), and interleukin 17 (IL-17).
Fibrotic remodeling is evaluated through analysis of collagen type I alpha 1 chain (COL1A1) and actin alpha 2 smooth muscle (ACTA2) expression using quantitative real-time polymerase chain reaction (RT-qPCR) and immunofluorescence. Epithelial barrier integrity is assessed by quantification of claudin-1, claudin-2, and mucin 2 (MUC2) expression, as well as functional measurement of transepithelial electrical resistance (TEER) in organoid-based systems.
Advanced multi-omics analyses are performed to characterize the immune-epithelial-stromal niche. Spatial transcriptomics (10x Genomics Visium) is used to map tissue-level transcriptional changes, integrated with single-cell RNA sequencing data to identify cell-type-specific responses and molecular pathways associated with treatment exposure. Bioinformatic analyses are conducted to define differentially regulated pathways and candidate biomarkers of response, with particular focus on refractory disease and fibrostenotic Crohn's disease phenotypes.
The study duration is 36 months, including patient recruitment and sample collection (months 4-18), ex vivo experimental procedures (months 6-20), multi-omics analyses (months 18-30), and data integration, interpretation, and dissemination (months 30-36).
Statistical analyses include assessment of normality using the Shapiro-Wilk test and homogeneity of variance using the Levene test. Group comparisons are performed using Student's t-test or Mann-Whitney U test for pairwise analyses, and one-way or two-way analysis of variance (ANOVA) with appropriate post hoc corrections (Bonferroni or Tukey). Non-parametric alternatives (Kruskal-Wallis test) are applied where appropriate. Statistical significance is defined as p < 0.05 (two-sided). Data analysis is performed using GraphPad Prism and R-based computational pipelines for high-dimensional biological data.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Ex vivo translational study using patient-derived intestinal biopsies, peripheral blood mononuclear cells, and organoid co-culture systems treated with human amniotic mesenchymal stromal cell (hAMSC)-derived secretome.
| Arm | Type | Receives |
|---|---|---|
| hAMSC secretome-treated samples | Other | Biological: Human amniotic mesenchymal stromal cell (hAMSC)-derived secretomeEx vivo treatment of patient-derived intestinal biopsies, peripheral blood mononuclear cells (PBMCs), and organoid co-culture systems with human amniotic mesenchymal stromal cell (hAMSC)-derived secretome. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human amniotic mesenchymal stromal cell (hAMSC)-derived secretomeAlso: amniotic MSC secretome, mesenchymal stromal cell secretome, conditioned medium hAMSC, extracellular vesicles hAMSCEx 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, epithelial, and stromal pathways. | Biological | hAMSC secretome-treated samples |
Primary outcome
Ex vivo modulation of immune cell populations by hAMSC-derived secretome
Time frame: Ex vivo assessment performed within 7 days of sample collection.
Frequency and activation status of T helper 1 (Th1), T helper 17 (Th17), regulatory T cells (Treg), and innate immune populations in patient-derived intestinal biopsies and peripheral blood mononuclear cells (PBMCs) after ex vivo exposure to hAMSC-derived secretome, assessed by multicolor flow cytometry.
Ex vivo modulation of inflammatory cytokines by hAMSC-derived secretome
Time frame: Ex vivo assessment performed within 7 days of sample collection.
Levels of key inflammatory and regulatory cytokines, including tumor necrosis factor alpha (TNF-α), interferon gamma (IFN-γ), interleukin 6 (IL-6), and interleukin 10 (IL-10), in supernatants of patient-derived intestinal biopsies and PBMCs after ex vivo exposure to hAMSC-derived secretome, assessed by multiplex cytokine assays.
Ex vivo modulation of fibrosis- and mucosal repair-related markers by hAMSC-derived secretome.
Time frame: Ex vivo assessment performed within 7 days of sample collection.
Molecular analysis of fibrosis- and mucosal repair-related markers expression in patient-derived intestinal biopsies and PBMCs after ex vivo exposure to hAMSC-derived secretome.
3 secondary outcomes
Intestinal epithelial barrier integrity and function
Time frame: Ex vivo analysis within 7 days of treatment
Transcriptomic and spatial omics profiling of immune-epithelial-fibrotic niche
Time frame: Within study period (months 6-30)
Immune-epithelial cross-talk modulation
Time frame: Ex vivo analysis within 7 days of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Human amniotic mesenchymal stromal cell (hAMSC)-derived secretome in people with Inflammatory Bowel Diseases, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
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 5 inclusion and 3 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: opening soon, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Ex vivo modulation of immune cell populations by hAMSC-derived secretome (time frame: Ex vivo assessment performed within 7 days of sample collection.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jul 2026.