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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028381
Receipt No. R000032488
Scientific Title A single-arm, open-label, phase 2 study of autologous CD34+ stem cells-selected transplantation for severe systemic sclerosis
Date of disclosure of the study information 2017/08/01
Last modified on 2018/01/10

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Basic information
Public title A single-arm, open-label, phase 2 study of autologous CD34+ stem cells-selected transplantation for severe systemic sclerosis
Acronym A clinical trial of autologous stem cell transplantation for severe systemic sclerosis
Scientific Title A single-arm, open-label, phase 2 study of autologous CD34+ stem cells-selected transplantation for severe systemic sclerosis
Scientific Title:Acronym A clinical trial of autologous stem cell transplantation for severe systemic sclerosis
Region
Japan

Condition
Condition Severe systemic sclerosis
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy of autologous CD34+ stem cells-selected transplantation for severe systemic sclerosis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes The mean change in modified Rodnan skin score at 12 months after transplantation
Key secondary outcomes The proportion of 25% improvement in skin score at 12 months
The mean change in forced vital capacity at 12 months
The mean change in serum KL-6 levels at 12 months
Event-free survival
Overall survival
Incidence of adverse events

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Device,equipment
Interventions/Control_1 Autologous CD34+ stem cells-selected transplantation
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
16 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria (1) definite diagnosis of Systemic Sclerosis using 2013 ACR/EULAR SSc criteria
(2) between the age of 16 and 65
(3) ECOG Performance Status of 0 to 2
(4) refractory to corticosteroids or immunosuppressive therapy
(5) fall under any of the following
a) with maximum disease duration of 4 years, minimum modified Rodnan skin score of 15 and organ involvement as follows:
1.interstitial pneumonia diagnosed by Chest Xp or CT and less than 80% in %FVC or %DLCO
2.past history of renal crisis
3.reversible heart failure, arrhythmia or pericardial effusion
b) with maximum disease duration of 2 years, minimum modified Rodnan skin score of 20 and erythrocyte sedimentation rate greater than 25 mm in the first hour and/or hemoglobin less than 11 g/dl
(6) able to understand and willing to sign the Informed Consent Form
Key exclusion criteria (1) severe organ dysfunction as following
a) severe arrhythmia leading to permanent implantation of a pacemaker or implantable cardioverter defibrillator, refractory chronic heart failure, reduced left ventricular ejection fraction lower than 50% at echocardiogram or severe pulmonary hypertension (mPAP >=30 mmHg)
b) severe lung dysfunction (PaO2 <60 mmHg under room air conditions, %FVC <50% or %DLOC <20%)
c) severe renal dysfunction (eGFR <40 ml/min or serum Cr >=2 mg/dl)
d)
d) liver abnormality (baseline AST, ALT or total bilirubin levels are >3 times higher than upper limit of normal)
(2) presence of malignancy except for complete remission
(3) presence of active infection
(4) positive for HBs-Ag, HCV-Ab, HIV-Ab or HTLV1-Ab test
(5) cumulative dose of more than 10 g of cyclophosphamide
(6) history of anaphylaxis or hypersensitivity to murine IgG or iron-dextran complex
(7) pregnancy or lactation
(8) judged by the investigator to be inappropriate for study participation
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichi Akashi
Organization Kyushu University Graduate school of Medicine
Division name Department of Medicine and Biosystemic Science
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL 092-642-5230
Email akashi@med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroki Mitoma
Organization Kyushu University hospital
Division name Department of Clinical Immunology and Rheumatology/Infectious Disease
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL 092-642-5228
Homepage URL
Email mitoma@intmed1.med.kyushu-u.ac.jp

Sponsor
Institute Department of Clinical Immunology and Rheumatology/Infectious Disease, Kyushu University Graduate school of Medicine
Institute
Department

Funding Source
Organization Department of Clinical Immunology and Rheumatology/Infectious Disease, Kyushu University Graduate school of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 九州大学病院

Other administrative information
Date of disclosure of the study information
2017 Year 08 Month 01 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 Open public recruiting
Date of protocol fixation
2017 Year 05 Month 11 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 07 Month 26 Day
Last modified on
2018 Year 01 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032488

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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