UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029841 |
|---|---|
| Receipt number | R000034088 |
| Scientific Title | Evaluation of amnion-derived mesenchymal stem cells for treatment-resistant moderate Crohn's disesase |
| Date of disclosure of the study information | 2017/11/13 |
| Last modified on | 2019/05/27 14:37:55 |
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Basic information
Public title
Evaluation of amnion-derived mesenchymal stem cells for treatment-resistant moderate Crohn's disesase
Acronym
Evaluation of amnion-derived mesenchymal stem cells for treatment-resistant moderate Crohn's disesase
Scientific Title
Evaluation of amnion-derived mesenchymal stem cells for treatment-resistant moderate Crohn's disesase
Scientific Title:Acronym
Evaluation of amnion-derived mesenchymal stem cells for treatment-resistant moderate Crohn's disesase
Region
| Japan |
Condition
Condition
Crohn's disease
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of intravenous administration of amnion-derived mesenchymal stem cells on treatment-resistant moderate Crohn's disease
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adverse events related to acute infusion toxicity
Key secondary outcomes
Adverse events in 52 weeks after first administration of MSCs.
Defects of investigational products.
CDAI, SESCD and IBDQ 4 weeks after first administration of MSCs and their time-course change up to 52 weeks.
Infiltration of macrophages and neutrophils in the inflamed tissue.
Serum levels of inflammatory markers (TNF-a, MCP-1, IL-1b, IL-10, MIF).
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Low dose group: 1,000,000 cells/kg (day 0 and day 7) DIV.
High dose group: 4,000,000 cells/kg (day 0 and day 7) DIV.
Safety in high dose group will be evaluated after confirmation of safety in 3 cases of low dose group.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Age 20-69.
2. Diagnosed as definitive Crohn's disease more than 24 weeks before registration.
3. Resistant or not tolerable to at least 2 biological products (Infliximab, Adalimumab, and Ustekinumab).
4. CDAI 200-450
5. Main lesion observed at ileum end or colorectum.
6. Patients who voluntarily signed the Institutional Review Board approved written informed consent.
Key exclusion criteria
(1) Patients with fistula with uncontrollable abscess.
(2) Patients with a history of total or subtotal colectomy.
(3) Patients with a history of small intestinal resection or short bowel syndrome.
(4) Patients with stoma, internal fistula or severe intestinal stricture.
(5) Patients who underwent surgery within 4 weeks before informed consent.
(6) Patients with a history of cancer in 5 years.
(7) Patients who received any medicine or treatment not allowed certain period before registration, and other medicine or treatment for clinical trials, and patients who received any medicine or treatment not allowed to start, stop or change the dose.
(8) Patients with uncontorollable systemic disease.
(9) Laboratory tests within these ranges
1) Hemoglobin <8.0 g/dL
2) White blood cell count <3,000/microliter
3) Lymphocyte count <500 microliter
4) AST >3x upper limit
5) ALT >3x upper limit
6) Total bilirubin >2.0 mg/dL
7) Serum creatinine >2x upper limit
(10) Patients who can not keep SpO2 of >94%
(11) Patients positive for HIV-Ab, HTLV-1-Ab, HBs Ag, HCV-Ab.
(12) Patients with uncontrollable severe infectious disease.
(13) Patients with severe hypersensitivity to bovine-derived constituents, human serum albumin and gentamicin.
(14) Patients with cancer, dysplasia or adenomatous polyp which needs to be treated in the colorectum.
(15) Patients with a history of hypersensitivity to iodine or iodine-containing contrast agent.
(16) Patients who had underwent any other treatment with cell therapy product.
(17) Patients with a history of any severe neurological disorder.
(18) Patients in pregnancy or breast-feeding, patients who want to be pregnant, patients who can not prevent conception.
(19) Patients considered as ineligible to the study.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shunsuke Ohnishi |
Organization
Hokkaido University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
N15, W7, Kita-ku, Sapporo, Japan
TEL
011-706-1161
sonishi@pop.med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shunsuke Ohnishi |
Organization
Hokkaido University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
N15, W7, Kita-ku, Sapporo, Japan
TEL
011-706-1161
Homepage URL
sonishi@pop.med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Hyogo Medical College
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
北海道大学病院（北海道）、兵庫医科大学病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2017 | Year | 09 | Month | 17 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 19 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 06 | Day |
Last modified on
| 2019 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034088
