Ulcerative ColitisPhase 1/2UCMSC-UCNCT02442037
Human Umbilical-Cord-Derived Mesenchymal Stem Cell Therapy in Active Ulcerative Colitis
A Phase 1/2 study testing UCMSC group in people with Ulcerative Colitis, run by Affiliated Hospital to Academy of Military Medical Sciences at 1 site in China.
Trial summary
Phase I-II Clinical Trial - Safety and efficacy of umbilical-cord-derived mesenchymal stem cell (UC-MSC) in patients with active ulcerative colitis，randomized, single blind, controlled prospective study. 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?
- UCMSC group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- May 2015to Dec 2017
- Phase
- Phase 1/2
- 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
- The diagnosis of active UC must have been confirmed by endoscopic and histological evidence.
- With mild and moderate disease.
- Men and women 18-65 years of age.
- Signed informed consent
- Capable of good communication with researchers and follow the entire test requirements
Who cannot join
- Patient with associated diseases such as diabetes mellitus, hypertension, dyslipidemia, atherosclerosis and malabsorption syndrome.
- With autoimmune diseases (lupus, HIV, cancer and hepatitis), colitis (infectious, post-radiation, post-drug, indeterminate) and Crohn's Disease.
- Abnormal hepatic or renal function
- Prior history of malignancy
- Pregnant or unwilling to practice contraceptive therapy or breast feeding females
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of gastroenterology,Affiliated Hospital to Academy of Military Medical Sciences
Beijing, 100071
Yan Liu, +86-010-66947473, 13911798288@163.com
Min Min, M.D.
About this study
Official title: Safety and Efficacy of Human Umbilical-Cord-derived Mesenchymal Stem Cell Transplantation in Active Ulcerative Colitis.
Phase I-II Clinical Trial - Safety and efficacy of umbilical-cord-derived mesenchymal stem cell (UC-MSC) in patients with active ulcerative colitis，randomized, single blind, controlled prospective study.
Read the detailed description
Phase I-II Clinical Trial - Safety and efficacy of umbilical-cord-derived mesenchymal stem cell (UC-MSC) in patients with active ulcerative colitis，randomized, single blind, controlled prospective study.
Thirty patients will be selected and randomized into two groups: the first group of 15 patients will receive a sole injection of UC-MSC and the remaining 15 patients will comprise the control group.
Every patient will maintain their standard treatment of active ulcerative colitis, with maximum tolerated dosage without side effects.
The day of infusion will be considered day zero. From that moment, followup will be divided into 0-1 week, 1 week-2 week,2 week-3 week, 3 week-1 month, and 3 month-6 months.
Clinical results will be analyzed after completion of 6 months of followup.
- Conditions
- Ulcerative Colitis
- Being tested
- UCMSC group, Control group(Normal saline)
- Keywords
- cellular therapy, active ulcerative colitis, phase 1/2 clinical study, human umbilical cord mesenchymal stem cell, allogeneic stem cell transplantation, UC
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UCMSC groupBiological
Human umbilical cord MSCs are transplanted three times by intravenous infusion(1×10^6/kg) ,once every week，a total of three times.
Control group(Normal saline)Other
Normal saline in same volume as MSCs are transplanted to patients.
| Study group | Role | What they receive |
|---|---|---|
| UCMSC group | Experimental | Human umbilical cord MSCs are administrated to patients by three intravenous infusion Receives: Biological: UCMSC group |
| Control group(Normal saline) | Other | Patients will receive normal saline at the same time points as that in experimental group. Receives: Other: Control group(Normal saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety will be determined by the assessment of major adverse events.
Safety will be determined by the assessment of major adverse events defined as fever, allergy or any other intravenous infusion adverse events.
Measured: Within the six months after intravenous infusion
Secondary outcomes (3)
Clinical response (CDAI points)
CDAI is defined as Clinical Disease Activity Index.
Measured: Post first cell transplantation: 3 weeks and months 1,3 and 6
Endoscopic improvement is assessed by UCEIS.
UCEIS is defined as Ulcerative Colitis Endoscopic Index of Severity.
Measured: Post first cell transplantation 6 months
Level of C-reactive protein
Measured: Post first cell transplantation: 3 weeks and months 1,3 and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2015 (estimated)
- Study startMay 2015
- Primary completionMay 2017 (estimated)
- Study completionDec 2017 (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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Ivy Institute of Stem Cells Co. Ltd
- Responsible party
- Sponsor
- Investigators
- Bing Liu, M.D., Study chair, 307-IVY Translational Medicine CenterYan Liu, M.D., Study director, Department of gastroenterology,Affiliated Hospital to Academy of Military Medical SciencesMin Min, M.D., Principal investigator, Department of gastroenterology,Affiliated Hospital to Academy of Military Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02442037
- Sponsor's protocol ID
- 307-IVY-SC-002
- Acronym
- UCMSC-UC
- Status last verified
- May 2015
- First submitted
- 6 May 2015
- Last updated
- 15 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Human Umbilical-Cord-derived Mesenchymal Stem Cell Transplantation in Active Ulcerative Colitis.
- ClinicalTrials.gov ID
- NCT02442037
- Acronym / sponsor ID
- UCMSC-UC / 307-IVY-SC-002
- Conditions
- Ulcerative Colitis
- Keywords
- cellular therapy, active ulcerative colitis, phase 1/2 clinical study, human umbilical cord mesenchymal stem cell, allogeneic stem cell transplantation, UC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical SciencesUniversity, hospital or other
- Collaborators
- Ivy Institute of Stem Cells Co. Ltd
- Study start
- May 2015
- Primary completion
- May 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 13 May 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.
Phase I-II Clinical Trial - Safety and efficacy of umbilical-cord-derived mesenchymal stem cell (UC-MSC) in patients with active ulcerative colitis，randomized, single blind, controlled prospective study.
Detailed description
Phase I-II Clinical Trial - Safety and efficacy of umbilical-cord-derived mesenchymal stem cell (UC-MSC) in patients with active ulcerative colitis，randomized, single blind, controlled prospective study.
Thirty patients will be selected and randomized into two groups: the first group of 15 patients will receive a sole injection of UC-MSC and the remaining 15 patients will comprise the control group.
Every patient will maintain their standard treatment of active ulcerative colitis, with maximum tolerated dosage without side effects.
The day of infusion will be considered day zero. From that moment, followup will be divided into 0-1 week, 1 week-2 week,2 week-3 week, 3 week-1 month, and 3 month-6 months.
Clinical results will be analyzed after completion of 6 months of followup.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UCMSC group | Experimental | Biological: UCMSC groupHuman umbilical cord MSCs are administrated to patients by three intravenous infusion |
| Control group(Normal saline) | Other | Other: Control group(Normal saline)Patients will receive normal saline at the same time points as that in experimental group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The diagnosis of active UC must have been confirmed by endoscopic and histological evidence.
- With mild and moderate disease.
- Men and women 18-65 years of age.
- Signed informed consent
- Capable of good communication with researchers and follow the entire test requirements
Key exclusion criteria (5 listed)
- Patient with associated diseases such as diabetes mellitus, hypertension, dyslipidemia, atherosclerosis and malabsorption syndrome.
- With autoimmune diseases (lupus, HIV, cancer and hepatitis), colitis (infectious, post-radiation, post-drug, indeterminate) and Crohn's Disease.
- Abnormal hepatic or renal function
- Prior history of malignancy
- Pregnant or unwilling to practice contraceptive therapy or breast feeding females
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 |
|---|---|---|
| UCMSC groupHuman umbilical cord MSCs are transplanted three times by intravenous infusion(1×10^6/kg) ,once every week，a total of three times. | Biological | UCMSC group |
| Control group(Normal saline)Normal saline in same volume as MSCs are transplanted to patients. | Other | Control group(Normal saline) |
Primary outcome
Safety will be determined by the assessment of major adverse events.
Time frame: Within the six months after intravenous infusion
Safety will be determined by the assessment of major adverse events defined as fever, allergy or any other intravenous infusion adverse events.
3 secondary outcomes
Clinical response (CDAI points)
Time frame: Post first cell transplantation: 3 weeks and months 1,3 and 6
Endoscopic improvement is assessed by UCEIS.
Time frame: Post first cell transplantation 6 months
Level of C-reactive protein
Time frame: Post first cell transplantation: 3 weeks and months 1,3 and 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2015.
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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.
Bing Liu, M.D. study chair
307-IVY Translational Medicine Center
Yan Liu, M.D. study director
Department of gastroenterology,Affiliated Hospital to Academy of Military Medical Sciences
Min Min, M.D. principal investigator
Department of gastroenterology,Affiliated Hospital to Academy of Military Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing UCMSC group in people with Ulcerative Colitis, run by Affiliated Hospital to Academy of Military Medical Sciences 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 5 inclusion and 5 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 15 May 2015. 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.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Yan Liu, M.D. (+86-010-66947473, 13911798288@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety will be determined by the assessment of major adverse events. (time frame: Within the six months after intravenous infusion). 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 15 May 2015.