Ulcerative ColitisNCT04882683
Clinical Study of Cord Blood Mononuclear Cells on Treatment of Hormone-resistant or Hormone-dependent Ulcerative Colitis
A study testing Prednisone, Azathioprine and Adalimumab in people with Ulcerative Colitis, run by Shandong Qilu Stem Cells Engineering Co., Ltd. at 1 site in China.
Trial summary
This study conducted a systematic clinical observation of the clinical efficacy of UCB-MNCs in the treatment of hormone-resistant or hormone-dependent ulcerative colitis, in order to observe its clinical safety and efficacy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Prednisone, Azathioprine and Adalimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2021to 31 Dec 2022
- Phase
- Interventional
- 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
- 1. Western medicine diagnosis is consistent with patients with refractory ulcerative colitis.
- 2. 18 Years to 65 Years，male or female.
- 3. Those who voluntarily participate in this clinical study and have signed an informed consent.
Who cannot join
- 1. Patients with non-refractory UC.
- 2. Those who are pregnant or breastfeeding, or have a childbirth plan in the near future.
- 3. People with severe allergies or allergies to known ingredients in basic treatments.
- 4. Patients with severe primary diseases such as severe cardiovascular and cerebrovascular diseases, liver and kidney, and hematopoietic system.
- 5. There are serious complications, such as local stenosis, intestinal obstruction, intestinal perforation, multiple intestinal polyps, toxic megacolon, rectal cancer, etc..
- 6. Patients with mental disorders and intellectual disabilities.
Show all 10Show fewer
- 7. Patients who have participated in clinical studies of other drugs in the past 3 months.
- 8. Those who are seriously ill and need emergency treatment.
- 9. Patients who are still undergoing other treatment options for ulcerative colitis.
- 10. Researchers believe that it is not suitable for entry.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Shandong, Shandong
xueliang Jiang, +86-15954103609, jiangxueliang678@126.com
About this study
This study conducted a systematic clinical observation of the clinical efficacy of UCB-MNCs in the treatment of hormone-resistant or hormone-dependent ulcerative colitis, in order to observe its clinical safety and efficacy.
Read the detailed description
This study adopts a randomized and controlled clinical research design. Patients are randomly divided into conventional treatment control group and UCB-MNCs treatment test group. The control group is given conventional treatment: prednisone combined azathioprine or adalimumab; the test group is given conventional treatment combined UCB-MNCs treatment, follow-up observations were carried out, in order to observe the clinical efficacy and safety of UCB-MNCs in the treatment of hormone resistance or hormone-dependent ulcerative colitis.
- Conditions
- Ulcerative Colitis
- Being tested
- Prednisone, Azathioprine, Adalimumab, umbilical cord blood mononuclear cells
- Keywords
- Ulcerative colitis, umbilical cord blood mononuclear cells, safety and efficacy
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoneDrug
Also called Deltacortone, Meticorten
0.75 mg per kilogram per day for three months
AzathioprineDrug
Also called Imurek, Imurel
1 mg per kilogram per day for three months
AdalimumabDrug
Also called Humira
40mg every two weeks for three months
umbilical cord blood mononuclear cellsBiological
Peripheral intravenous infusion method, infusion of umbilical cord blood mononuclear cell suspension 50ml (cell number 2×10^8).
| Study group | Role | What they receive |
|---|---|---|
| control group | Experimental | Prednisone+Azathioprine/Adalimumab Receives: Drug: Prednisone; Drug: Azathioprine; Drug: Adalimumab |
| UCB-MNCs group | Experimental | Prednisone+Azathioprine/Adalimumab+UCB-MNCs Receives: Drug: Prednisone; Drug: Azathioprine; Drug: Adalimumab; Biological: umbilical cord blood mononuclear cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical efficacy rate
According to the method of modified Mayo score calculation, it is defined as a decrease of ≥30% of the score or a decrease of ≥3 points relative to the baseline value, and a decrease of ≥1 point or a score of 0 or 1 in the sub-item score of blood in the stool, and this type of patient is judged Effective for treatment. Clinical effective rate = (effective number of people / total number of people in this group ) × 100%.
Measured: Change from Baseline Clinical efficacy rate at 8th and 16th week, and the first week after the end of treatment.
Clinical response rate
According to the method of modified Mayo score calculation, it is defined as a score ≤ 2 points and no single sub-item score> 1 point. Clinical remission rate =(number of remissions / total number of people in this group) × 100%.
Measured: Change from Baseline Clinical response rate at 8th and 16th week, and the first week after the end of treatment.
Secondary outcomes (3)
Clinical symptom score
According to the scoring criteria for individual symptoms (diarrhea, mucus pus and blood in the stool, abdominal pain, tenesmus), the severity of symptoms is divided into 0, 2, 4, and 6 points. The higher the score, the more severe the symptoms.
Measured: Change from Baseline clinical symptom score at the first week after the end of treatment.
Endoscopic response rate
According to the method of modified Mayo score, endoscopy found that the score decreased by at least 1 point from baseline. Endoscopic response rate = (number of endoscopic responders/total number of people in the group) × 100%.
Measured: Change from Baseline endoscopic response rate at the first week after the end of treatment.
Mucosal healing rate
According to the method of modified Mayo score, the absolute score of the endoscopy discovery score is 0 or 1 point. Mucosal healing rate = (mucosal healing number / total number of people in this group) × 100%.
Measured: Change from Baseline mucosal healing rate at the first week after the end of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start1 Jun 2021 (estimated)
- Primary completion1 Jun 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Qilu Stem Cells Engineering Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04882683
- Sponsor's protocol ID
- UCB-MNCs-UC-2021
- Status last verified
- May 2021
- First submitted
- 6 May 2021
- Last updated
- 12 May 2021
- Results posted
- 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 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Cord Blood Mononuclear Cells on Treatment of Hormone-resistant or Hormone-dependent Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT04882683
- Acronym / sponsor ID
- UCB-MNCs-UC-2021
- Conditions
- Ulcerative Colitis
- Keywords
- Ulcerative colitis, umbilical cord blood mononuclear cells, safety and efficacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shandong Qilu Stem Cells Engineering Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 12 May 2021 (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 study conducted a systematic clinical observation of the clinical efficacy of UCB-MNCs in the treatment of hormone-resistant or hormone-dependent ulcerative colitis, in order to observe its clinical safety and efficacy.
Detailed description
This study adopts a randomized and controlled clinical research design. Patients are randomly divided into conventional treatment control group and UCB-MNCs treatment test group. The control group is given conventional treatment: prednisone combined azathioprine or adalimumab; the test group is given conventional treatment combined UCB-MNCs treatment, follow-up observations were carried out, in order to observe the clinical efficacy and safety of UCB-MNCs in the treatment of hormone resistance or hormone-dependent ulcerative colitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Experimental | Drug: Prednisone, Drug: Azathioprine, Drug: AdalimumabPrednisone+Azathioprine/Adalimumab |
| UCB-MNCs group | Experimental | Drug: Prednisone, Drug: Azathioprine, Drug: Adalimumab, Biological: umbilical cord blood mononuclear cellsPrednisone+Azathioprine/Adalimumab+UCB-MNCs |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1. Western medicine diagnosis is consistent with patients with refractory ulcerative colitis.
- 2. 18 Years to 65 Years，male or female.
- 3. Those who voluntarily participate in this clinical study and have signed an informed consent.
Key exclusion criteria (10 listed)
- 1. Patients with non-refractory UC.
- 2. Those who are pregnant or breastfeeding, or have a childbirth plan in the near future.
- 3. People with severe allergies or allergies to known ingredients in basic treatments.
- 4. Patients with severe primary diseases such as severe cardiovascular and cerebrovascular diseases, liver and kidney, and hematopoietic system.
- 5. There are serious complications, such as local stenosis, intestinal obstruction, intestinal perforation, multiple intestinal polyps, toxic megacolon, rectal cancer, etc..
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 |
|---|---|---|
| PrednisoneAlso: Deltacortone, Meticorten0.75 mg per kilogram per day for three months | Drug | UCB-MNCs group, control group |
| AzathioprineAlso: Imurek, Imurel1 mg per kilogram per day for three months | Drug | UCB-MNCs group, control group |
| AdalimumabAlso: Humira40mg every two weeks for three months | Drug | UCB-MNCs group, control group |
| umbilical cord blood mononuclear cellsPeripheral intravenous infusion method, infusion of umbilical cord blood mononuclear cell suspension 50ml (cell number 2×10^8). | Biological | UCB-MNCs group |
Primary outcome
Clinical efficacy rate
Time frame: Change from Baseline Clinical efficacy rate at 8th and 16th week, and the first week after the end of treatment.
According to the method of modified Mayo score calculation, it is defined as a decrease of ≥30% of the score or a decrease of ≥3 points relative to the baseline value, and a decrease of ≥1 point or a score of 0 or 1 in the sub-item score of blood in the stool, and this type of patient is judged Effective for treatment. Clinical effective rate = (effective number of people / total number of people in this group ) × 100%.
Clinical response rate
Time frame: Change from Baseline Clinical response rate at 8th and 16th week, and the first week after the end of treatment.
According to the method of modified Mayo score calculation, it is defined as a score ≤ 2 points and no single sub-item score> 1 point. Clinical remission rate =(number of remissions / total number of people in this group) × 100%.
3 secondary outcomes
Clinical symptom score
Time frame: Change from Baseline clinical symptom score at the first week after the end of treatment.
Endoscopic response rate
Time frame: Change from Baseline endoscopic response rate at the first week after the end of treatment.
Mucosal healing rate
Time frame: Change from Baseline mucosal healing rate at the first week after the end of treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2021.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prednisone, Azathioprine and Adalimumab in people with Ulcerative Colitis, run by Shandong Qilu Stem Cells Engineering Co., Ltd. at 1 site in China.
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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 12 May 2021. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact xueliang C Jiang (+8615954103609, jiangxueliang678@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical efficacy rate (time frame: Change from Baseline Clinical efficacy rate at 8th and 16th week, and the first week after the end of treatment.). 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 12 May 2021.