Crohn's DiseasesPhase 1NCT07822087
A Phase 1 Study of ATORM-C in Patients With Crohn's Disease
A Phase 1 study testing Autologous Adult Stem Cell-Derived Intestinal Organoid in people with Crohn's Diseases and Crohn's Disease, run by ORGANOIDSCIENCES LTD. at 1 site in South Korea.
Trial summary
This Phase 1 study evaluates the safety and tolerability of ATORM-C in patients with Crohn's disease. ATORM-C is an investigational product consisting of autologous adult stem cell-derived intestinal organoids. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Crohn's Diseases, Crohn's Disease
- What is being tested?
- Autologous Adult Stem Cell-Derived Intestinal Organoid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2026to Aug 2028
- Phase
- Phase 1
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 19 years or older and younger than 80 years at the time of screening (male or female).
- Diagnosed with Crohn's disease at least 6 months prior to screening, confirmed by imaging, tissue sampling (biopsy), and/or colonoscopy.
- Have had an inadequate response to at least 6 months of standard treatment for Crohn's disease (such as anti-inflammatory drugs, oral corticosteroids, immunosuppressants, or biologic agents). Inadequate response means failure to achieve ulcer-free endoscopy, defined as an SES-CD Ulcerated Surface Score of 0 or 1.
- Have active daily symptoms at screening and right before treatment, defined as either an average of 4 or more loose/liquid stools per day or an average daily abdominal pain score of 2 or more, based on the corresponding CDAI components.
- Meet all of the following colonoscopy findings at screening:
- Have at least one active ulcer in an accessible area of the intestine (such as the colon or ileocecal region).
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- Have at least one ulcer with a longest diameter of 5 mm or larger.
- Have an active ulcer segment with an endoscopic severity score (SES-CD) of 6 or higher, with an ulcer size score of 2 or higher and no narrowing or blockage (stricture score of 0) in that area.
- Meet all required blood test standards for cell therapy donor eligibility.
- Voluntarily agree to participate and sign the written informed consent form after receiving a full explanation of the study.
Who cannot join
- Other Inflammatory Bowel Conditions: Diagnosed with ulcerative colitis or unclassified colitis.
- Surgical Needs: Require, or are expected to require, surgery for Crohn's disease or its complications.
- Severe Co-existing Conditions: Have a severe autoimmune disease other than Crohn's disease, or an active abdominal/perianal condition (such as an undrained abscess or active fistula).
- Recent Surgeries: Had bowel resection within 6 months or intra-abdominal surgery within 3 months prior to screening.
- Procedure Inability: Unable to safely undergo bowel preparation, colonoscopy, or sedation, or have a known allergy/contraindication to medications used during these procedures.
- Uncontrolled Medical Issues: Have a clinically significant or poorly controlled medical condition, such as severe heart, bleeding, kidney, or liver disease, or uncontrolled diabetes.
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- Active Severe Infection: Have an active, severe infection requiring ongoing medical treatment.
- Cancer History: Have a history of cancer (malignancy) within 5 years before screening, except for specific low-risk cancers permitted by the protocol.
- Allergies to Study Treatment: Have a known severe allergy (hypersensitivity) to ATORM-C, its ingredients, or materials used in its manufacturing.
- Prohibited Therapies or Transplants: Are taking prohibited medications, have previously received any cell therapy product, or have received an organ transplant (except corneal transplant).
- Significant Blood Test Abnormalities: Have severe laboratory test abnormalities, including liver function (AST or ALT ≥3 times the upper limit of normal), kidney function (eGFR <30 mL/min/1.73 m²), bleeding markers (PT INR >1.5), or low blood platelets (<50,000/mm³).
- Pregnancy, Breastfeeding, or Contraception: Are pregnant, breastfeeding, or unwilling to follow the protocol-specified contraception requirements during the study.
- Recent Clinical Trials: Received another investigational drug or device within 4 weeks prior to screening.
- Investigator Judgment: Deemed unsuitable for participation by the study investigator for any other safety reason.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul, 05505
Byong Duk Ye, MD, +82-70-4105-0960, ey_lee@organoidrx.com
About this study
Official title: An Open, Sequential Dose-Escalation, Single-Center, Phase 1 Clinical Trial to Evaluate Tolerability, Safety, and Exploratory Efficacy of ATORM-C in Patients With Crohn's Disease
This Phase 1 study evaluates the safety and tolerability of ATORM-C in patients with Crohn's disease. ATORM-C is an investigational product consisting of autologous adult stem cell-derived intestinal organoids. Participants will receive a single dose of ATORM-C applied directly to a target intestinal ulcer during colonoscopy. The study will also explore the effect of ATORM-C on intestinal ulcer healing.
Read the detailed description
This is an open-label, sequential dose-escalation Phase 1 study to evaluate the safety, tolerability, and exploratory efficacy of ATORM-C across three dose levels in patients with Crohn's disease. ATORM-C is manufactured by culturing and expanding autologous adult stem cell-derived intestinal organoids isolated from each participant's intestinal tissue. Participants will receive a single administration of ATORM-C directly applied to a target intestinal ulcer during colonoscopy. Primary evaluations will focus on safety and tolerability, with exploratory assessments of ATORM-C's effect on intestinal ulcer healing.
- Conditions
- Crohn's Diseases, Crohn's Disease
- Being tested
- Autologous Adult Stem Cell-Derived Intestinal Organoid
- Keywords
- Crohn Disease, Intestinal Organoid, Autologous Organoid, Intestinal Ulcer, ATORM-C, Autologous Adult Stem Cell-Derived Intestinal Organoid, Dose Escalation, Crohn's disease
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Adult Stem Cell-Derived Intestinal OrganoidBiological
ATORM-C is an investigational product consisting of autologous adult stem cell-derived intestinal organoids. Participants will receive a single administration of ATORM-C applied directly to the target intestinal ulcer during colonoscopy. ATORM-C is administered with fibrin glue (Greenplast-Q) to facilitate local application to the target ulcer.
| Study group | Role | What they receive |
|---|---|---|
| Low-Dose ATORM-C | Experimental | 16,330 organoids (0.2 mL) per cm² of ulcer area Receives: Biological: Autologous Adult Stem Cell-Derived Intestinal Organoid |
| Medium-Dose ATORM-C | Experimental | 81,650 organoids (0.2 mL) per cm² of ulcer area Receives: Biological: Autologous Adult Stem Cell-Derived Intestinal Organoid |
| High-Dose ATORM-C | Experimental | 163,300 organoids (0.2 mL) per cm² of ulcer area Receives: Biological: Autologous Adult Stem Cell-Derived Intestinal Organoid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-Limiting Toxicities (DLTs)
Occurrence of dose-limiting toxicities (DLTs). A DLT is defined as any Grade 3 or higher adverse reaction according to NCI CTCAE v5.0 that is assessed as possibly, probably, or certainly related to ATORM-C. CTCAE grades range from Grade 1 (mild) to Grade 5 (death related to an adverse event), with higher grades indicating greater severity.
Measured: From ATORM-C administration through 4 weeks post-dose
Determination of Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)
The MTD and RP2D of ATORM-C will be determined based on the occurrence of dose-limiting toxicities (DLTs) during the dose-escalation period and the overall safety and tolerability of ATORM-C.
Measured: From ATORM-C administration through 24 weeks post-dose
Secondary outcomes (7)
Incidence of Adverse Events (AEs) and Adverse Events of Special Interest (AESIs)
Occurrence of treatment-emergent adverse events (TEAEs), adverse drug reactions (ADRs), serious adverse events (SAEs), serious adverse drug reactions (SADRs), adverse events of special interest (AESIs), and administration site local adverse events. Adverse events leading to discontinuation of study treatment or death will also be evaluated.
Measured: From ATORM-C administration through 24 weeks post-dose
Changes in Clinical Laboratory Tests, Vital Signs, Physical Examinations, and 12-Lead Electrocardiograms (ECGs)
Changes from baseline in continuous safety parameters, including clinical laboratory tests and vital signs, evaluated at protocol-specified visits. Occurrence of clinically significant abnormalities (Abnormal CS) in clinical laboratory tests, physical examinations, and 12-lead electrocardiograms (ECGs) post-dose will also be evaluated.
Measured: Baseline through 24 weeks post-dose, at protocol-specified visits
Change from Baseline in Target Ulcer Size
Absolute change and percentage change from baseline in the size of the target ulcer, evaluated based on the longest diameter, shortest diameter, and total surface area measured during colonoscopy at protocol-specified time points.
Measured: Baseline and Weeks 4, 12, and 24 post-dose
Change from Baseline in Modified Global Histologic Disease Activity Score (Modified GHAS) of the Target Ulcer
Change from baseline in the Modified Global Histologic Disease Activity Score (Modified GHAS) based on histologic evaluation of mucosal biopsy specimens collected from the target ulcer. The regional Modified GHAS ranges from 0 to 12, with higher scores indicating greater histologic disease activity.
Measured: Baseline and Week 24 post-dose
Change from Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) of the Target Ulcer
Change from baseline in the Simple Endoscopic Score for Crohn's Disease (SES-CD) total score and ulcer size subscore evaluated specifically for the target ulcer via colonoscopy. The SES-CD assessed for the target ulcer evaluates 4 endoscopic variables, each scored from 0 to 3, yielding a target ulcer regional score ranging from 0 to 12. Higher scores indicate greater endoscopic disease activity.
Measured: Baseline and Weeks 4, 12, and 24 post-dose
Proportion of Participants Achieving ≥50% Reduction from Baseline in SES-CD Score of the Target Ulcer
Percentage of participants who achieve a 50% or greater reduction from baseline in the Simple Endoscopic Score for Crohn's Disease (SES-CD) total score for the target ulcer at Week 24 post-dose. The regional target ulcer SES-CD ranges from 0 to 12, with higher scores indicating greater endoscopic disease activity.
Measured: Baseline and Week 24 post-dose
Proportion of Participants Achieving Endoscopic Remission of the Target Ulcer
Percentage of participants achieving endoscopic remission of the target ulcer at Week 24 post-dose. Endoscopic remission is defined as a Simple Endoscopic Score for Crohn's Disease (SES-CD) total score of less than 2 (<2) for the target ulcer. The regional target ulcer SES-CD ranges from 0 to 12, with higher scores indicating greater endoscopic disease activity.
Measured: Baseline and Weeks 4, 12, and 24 post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseasesStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- A standard 3+3 sequential dose-escalation design with three dose levels of ATORM-C. Dose escalation will be based on the occurrence of dose-limiting toxicities (DLTs) in the preceding cohort.
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ORGANOIDSCIENCES LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07822087
- Sponsor's protocol ID
- ATORM-C_CD-101
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 16 Sep 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 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Sequential Dose-Escalation, Single-Center, Phase 1 Clinical Trial to Evaluate Tolerability, Safety, and Exploratory Efficacy of ATORM-C in Patients With Crohn's Disease
- ClinicalTrials.gov ID
- NCT07822087
- Acronym / sponsor ID
- ATORM-C_CD-101
- Conditions
- Crohn's Diseases, Crohn's Disease
- Keywords
- Crohn Disease, Intestinal Organoid, Autologous Organoid, Intestinal Ulcer, ATORM-C, Autologous Adult Stem Cell-Derived Intestinal Organoid, Dose Escalation, Crohn's disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- ORGANOIDSCIENCES LTD.Industry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 16 Sep 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.
This Phase 1 study evaluates the safety and tolerability of ATORM-C in patients with Crohn's disease. ATORM-C is an investigational product consisting of autologous adult stem cell-derived intestinal organoids. Participants will receive a single dose of ATORM-C applied directly to a target intestinal ulcer during colonoscopy. The study will also explore the effect of ATORM-C on intestinal ulcer healing.
Detailed description
This is an open-label, sequential dose-escalation Phase 1 study to evaluate the safety, tolerability, and exploratory efficacy of ATORM-C across three dose levels in patients with Crohn's disease. ATORM-C is manufactured by culturing and expanding autologous adult stem cell-derived intestinal organoids isolated from each participant's intestinal tissue. Participants will receive a single administration of ATORM-C directly applied to a target intestinal ulcer during colonoscopy. Primary evaluations will focus on safety and tolerability, with exploratory assessments of ATORM-C's effect on intestinal ulcer healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A standard 3+3 sequential dose-escalation design with three dose levels of ATORM-C. Dose escalation will be based on the occurrence of dose-limiting toxicities (DLTs) in the preceding cohort.
| Arm | Type | Receives |
|---|---|---|
| Low-Dose ATORM-C | Experimental | Biological: Autologous Adult Stem Cell-Derived Intestinal Organoid16,330 organoids (0.2 mL) per cm² of ulcer area |
| Medium-Dose ATORM-C | Experimental | Biological: Autologous Adult Stem Cell-Derived Intestinal Organoid81,650 organoids (0.2 mL) per cm² of ulcer area |
| High-Dose ATORM-C | Experimental | Biological: Autologous Adult Stem Cell-Derived Intestinal Organoid163,300 organoids (0.2 mL) per cm² of ulcer area |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Aged 19 years or older and younger than 80 years at the time of screening (male or female).
- Diagnosed with Crohn's disease at least 6 months prior to screening, confirmed by imaging, tissue sampling (biopsy), and/or colonoscopy.
- Have had an inadequate response to at least 6 months of standard treatment for Crohn's disease (such as anti-inflammatory drugs, oral corticosteroids, immunosuppressants, or biologic agents). Inadequate response means failure to achieve ulcer-free endoscopy, defined as an SES-CD Ulcerated Surface Score of 0 or 1.
- Have active daily symptoms at screening and right before treatment, defined as either an average of 4 or more loose/liquid stools per day or an average daily abdominal pain score of 2 or more, based on the corresponding CDAI components.
- Meet all of the following colonoscopy findings at screening:
Key exclusion criteria (14 listed)
- Other Inflammatory Bowel Conditions: Diagnosed with ulcerative colitis or unclassified colitis.
- Surgical Needs: Require, or are expected to require, surgery for Crohn's disease or its complications.
- Severe Co-existing Conditions: Have a severe autoimmune disease other than Crohn's disease, or an active abdominal/perianal condition (such as an undrained abscess or active fistula).
- Recent Surgeries: Had bowel resection within 6 months or intra-abdominal surgery within 3 months prior to screening.
- Procedure Inability: Unable to safely undergo bowel preparation, colonoscopy, or sedation, or have a known allergy/contraindication to medications used during these procedures.
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 |
|---|---|---|
| Autologous Adult Stem Cell-Derived Intestinal OrganoidATORM-C is an investigational product consisting of autologous adult stem cell-derived intestinal organoids. Participants will receive a single administration of ATORM-C applied directly to the target intestinal ulcer during colonoscopy. ATORM-C is administered with fibrin glue (Greenplast-Q) to facilitate local application to the target ulcer. | Biological | High-Dose ATORM-C, Low-Dose ATORM-C, Medium-Dose ATORM-C |
Primary outcome
Dose-Limiting Toxicities (DLTs)
Time frame: From ATORM-C administration through 4 weeks post-dose
Occurrence of dose-limiting toxicities (DLTs). A DLT is defined as any Grade 3 or higher adverse reaction according to NCI CTCAE v5.0 that is assessed as possibly, probably, or certainly related to ATORM-C. CTCAE grades range from Grade 1 (mild) to Grade 5 (death related to an adverse event), with higher grades indicating greater severity.
Determination of Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)
Time frame: From ATORM-C administration through 24 weeks post-dose
The MTD and RP2D of ATORM-C will be determined based on the occurrence of dose-limiting toxicities (DLTs) during the dose-escalation period and the overall safety and tolerability of ATORM-C.
7 secondary outcomes
Incidence of Adverse Events (AEs) and Adverse Events of Special Interest (AESIs)
Time frame: From ATORM-C administration through 24 weeks post-dose
Changes in Clinical Laboratory Tests, Vital Signs, Physical Examinations, and 12-Lead Electrocardiograms (ECGs)
Time frame: Baseline through 24 weeks post-dose, at protocol-specified visits
Change from Baseline in Target Ulcer Size
Time frame: Baseline and Weeks 4, 12, and 24 post-dose
Change from Baseline in Modified Global Histologic Disease Activity Score (Modified GHAS) of the Target Ulcer
Time frame: Baseline and Week 24 post-dose
Change from Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) of the Target Ulcer
Time frame: Baseline and Weeks 4, 12, and 24 post-dose
Proportion of Participants Achieving ≥50% Reduction from Baseline in SES-CD Score of the Target Ulcer
Time frame: Baseline and Week 24 post-dose
Proportion of Participants Achieving Endoscopic Remission of the Target Ulcer
Time frame: Baseline and Weeks 4, 12, and 24 post-dose
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 16 Sep 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Autologous Adult Stem Cell-Derived Intestinal Organoid in people with Crohn's Diseases and Crohn's Disease, run by ORGANOIDSCIENCES LTD. at 1 site in South Korea.
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 10 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 16 Sep 2026. 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 South Korea. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-Limiting Toxicities (DLTs) (time frame: From ATORM-C administration through 4 weeks post-dose). The study lists 2 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 16 Sep 2026.