Crohn's DiseasePhase 1TolDecCDintraNCT02622763
Intralesional Tolerogenic Dendritic Cells in Crohn's Disease Treatment
A Phase 1 study testing Tolerogenic Dendritic Cells in people with Crohn's Disease, run by Fundacion Clinic per a la Recerca Biomédica at 1 site in Spain.
Trial summary
Intralesional Tolerogenic Dendritic Cells in Crohn's Disease Treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Tolerogenic Dendritic Cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2015to 5 May 2019
- Phase
- Phase 1
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of Crohn's disease ( Lennard -Jones criteria )
- Active Crohn's disease in the last six months to the inclusion defined as : CDAI? 220 and endoscopic or radiological criteria of activity
- Refractory or intolerance to conventional therapy including corticosteroids , immunomodulators and anti-tumor necrosis factor-alpha
- Presence of visible lesions by endoscopy
- Acceptance to participate in the study and written informed consent
Who cannot join
- No injuries in pre-screening resonance
- Pregnancy, lactation or women of childbearing age not taking appropriate contraceptive measures
- Patients HIV + and Hepatitis C Virus + Hepatitis B Virus +
- Serious concomitant disease:
- Renal failure with creatinine clearance < 40ml / min
- Heart disease: congestive heart failure with ejection fraction < 45 % , atrial fibrillation treated with oral anticoagulants, uncontrolled ventricular arrhythmias , pericarditis , pleural effusion with hemodynamic
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- Neoplasms or myelodysplasia
- Psychiatric disorders including alcohol and drugs
- Symptoms attributable to fibrotic strictures in Crohn's disease at the discretion of the investigators
- Diarrhea attributable to " short bowel syndrome"
- Active infection , including tuberculosis
- Participation in research studies of new drugs in the 3 months prior to inclusion.
- Vaccination with live/attenuated germs in the previous 3 months
- Personal history of cancer (active or complete remission) or known family history of hereditary cancer.
- Patients in whom , after observation of the state of their veins , these are considered inaccessible and impossible to perform apheresis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Clinical Efficacy Evaluation of Intralesional Administration of Tolerogenic Dendritic Cells in Patients With Refractory Crohn's Disease
Intralesional Tolerogenic Dendritic Cells in Crohn's Disease Treatment.
Read the detailed description
The main objective is to evaluate the safety and clinical response of intralesional injection of Autologous peripheral blood differentiated adult dendritic cells expanded tolerogenic in patients with refractory Crohn's disease treatment.
- Conditions
- Crohn's Disease
- Being tested
- Tolerogenic Dendritic Cells
- Keywords
- Tolerogenic Dendritic Cells
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tolerogenic Dendritic CellsBiological
Intralesional administration
| Study group | Role | What they receive |
|---|---|---|
| 10 millions dose | Experimental | a total of 10 millions tolerogenic dendritic cells Receives: Biological: Tolerogenic Dendritic Cells |
| 100 millions dose | Experimental | a total of 100 millions tolerogenic dendritic cells Receives: Biological: Tolerogenic Dendritic Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events
Measured: from inclusion up to 12 weeks
Proportion of patients with clinical response defined as a decrease of Crohn 's Disease Activity Index > 100 points
Measured: up to 12 weeks
Secondary outcomes (4)
The proportion of patients with clinical response defined as a decrease of Crohn 's Disease Activity Index > 100 points
Measured: from baseline to week 12
The proportion of patients in clinical remission defined as Crohn 's Disease Activity Index < 150 points
Measured: at week 12
Endoscopic lesions using the Crohn 's Disease Endoscopic Index of Severity ". Endoscopic remission was defined as the absence of ulcers
Measured: at baseline and week 12
The evaluation of quality of life will be held by Inflammatory bowel disease questionnaire Immunological endpoints
Measured: Change from baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2015 (estimated)
- Study startNov 2015
- Primary completion5 May 2019
- Study completion5 May 2019
Why it stopped: low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion Clinic per a la Recerca Biomédica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Varea, Fundacion Clinic per a la Recerca Biomédica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02622763
- Sponsor's protocol ID
- TolDec-CD-intra
- Other IDs
- 2014-001083-35, 2014
- Acronym
- TolDecCDintra
- Status last verified
- Feb 2020
- First submitted
- 1 Dec 2015
- Last updated
- 28 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Clinical Efficacy Evaluation of Intralesional Administration of Tolerogenic Dendritic Cells in Patients With Refractory Crohn's Disease
- ClinicalTrials.gov ID
- NCT02622763
- Acronym / sponsor ID
- TolDecCDintra / TolDec-CD-intra
- Conditions
- Crohn's Disease
- Keywords
- Tolerogenic Dendritic Cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low recruitment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Fundacion Clinic per a la Recerca BiomédicaUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- 5 May 2019 (actual)
- Study completion
- 5 May 2019 (actual)
- First posted
- 4 Dec 2015 (estimated)
- 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.
Intralesional Tolerogenic Dendritic Cells in Crohn's Disease Treatment.
Detailed description
The main objective is to evaluate the safety and clinical response of intralesional injection of Autologous peripheral blood differentiated adult dendritic cells expanded tolerogenic in patients with refractory Crohn's disease treatment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10 millions dose | Experimental | Biological: Tolerogenic Dendritic Cellsa total of 10 millions tolerogenic dendritic cells |
| 100 millions dose | Experimental | Biological: Tolerogenic Dendritic Cellsa total of 100 millions tolerogenic dendritic cells |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed diagnosis of Crohn's disease ( Lennard -Jones criteria )
- Active Crohn's disease in the last six months to the inclusion defined as : CDAI? 220 and endoscopic or radiological criteria of activity
- Refractory or intolerance to conventional therapy including corticosteroids , immunomodulators and anti-tumor necrosis factor-alpha
- Presence of visible lesions by endoscopy
- Acceptance to participate in the study and written informed consent
Key exclusion criteria (15 listed)
- No injuries in pre-screening resonance
- Pregnancy, lactation or women of childbearing age not taking appropriate contraceptive measures
- Patients HIV + and Hepatitis C Virus + Hepatitis B Virus +
- Serious concomitant disease:
- Symptoms attributable to fibrotic strictures in Crohn's disease at the discretion of the investigators
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 |
|---|---|---|
| Tolerogenic Dendritic CellsIntralesional administration | Biological | 10 millions dose, 100 millions dose |
Primary outcome
Number of adverse events
Time frame: from inclusion up to 12 weeks
Proportion of patients with clinical response defined as a decrease of Crohn 's Disease Activity Index > 100 points
Time frame: up to 12 weeks
4 secondary outcomes
The proportion of patients with clinical response defined as a decrease of Crohn 's Disease Activity Index > 100 points
Time frame: from baseline to week 12
The proportion of patients in clinical remission defined as Crohn 's Disease Activity Index < 150 points
Time frame: at week 12
Endoscopic lesions using the Crohn 's Disease Endoscopic Index of Severity ". Endoscopic remission was defined as the absence of ulcers
Time frame: at baseline and week 12
The evaluation of quality of life will be held by Inflammatory bowel disease questionnaire Immunological endpoints
Time frame: Change from baseline to week 12
Results and safety
The study was stopped early (reason given: low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Tolerogenic Dendritic Cells in people with Crohn's Disease, run by Fundacion Clinic per a la Recerca Biomédica at 1 site in Spain.
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 15 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: stopped early, as of the sponsor's last update on 28 Feb 2020. 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 Spain. 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?
The study was stopped early (reason given: low recruitment). Results are not available in the source record.
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?
Number of adverse events (time frame: from inclusion up to 12 weeks). 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 28 Feb 2020.