UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037339 |
|---|---|
| Receipt number | R000042515 |
| Scientific Title | G-CSF mobilized CD34+ cell transplantation as regenerative medicine for patients with critical limb ischemia. |
| Date of disclosure of the study information | 2019/07/16 |
| Last modified on | 2020/03/16 17:09:39 |
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Basic information
Public title
G-CSF mobilized CD34+ cell transplantation as regenerative medicine for patients with critical limb ischemia.
Acronym
CD34+ cell transplantation for patients with CLI.
Scientific Title
G-CSF mobilized CD34+ cell transplantation as regenerative medicine for patients with critical limb ischemia.
Scientific Title:Acronym
CD34+ cell transplantation for patients with CLI.
Region
| Japan |
Condition
Condition
Critical limb ischemia in patients undergoing hemodialysis
Classification by specialty
| Cardiology | Nephrology | Vascular surgery |
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of safety and efficacy of G-CSF mobilized autologous peripheral blood derived CD34+ cell transplantation in hemodialysis patients with critical limb ischemia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety and efficacy evaluation of the therapy for 52 weeks
Key secondary outcomes
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
| Other |
Interventions/Control_1
Intra-muscular injection of G-CSF mobilized autologous peripheral blood derived CD34+ cell
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Atherosclerotic peripheral arterial disease with greater than or equal to 70% luminal stenosis or obstruction in the leg arteries by digital subtraction angiography
2) Undergoing hemodialysis
3) More than 12 weeks since the onset of lower limb ischemia
4) Rutherford category of 4-5
5) Failure of or no indication for transluminal angioplasty/stenting and bypass surgery
Key exclusion criteria
1) Rutherford category of 6
2) Buerger's disease
3) Within 4 weeks after revascularization therapy (bypass surgery or endovascular therapy) or low-density lipoprotein apheresis
4) Severely decreased cardiac function (under 25% of left ventricular ejection fraction on cardiac ultrasonography)
5) Allergic reaction or adverse reaction to G-CSF, the other reagents, or apheresis
6) Malignancy or history of malignancy within past 5 years
7) Advanced diabetic retinopathy
8) Within 12 weeks after myocardial infarction, unstable angina pectoris, or stroke
9) Hematologic disease (leukemia, myeloproliferative disorders, myelodysplastic syndromes, or sickle cell disease)
10) Autoimmune disorders
11) Liver cirrhosis
12) Interstitial pneumonitis or history
13) At least one laboratory abnormality (white blood cell count, under 3,000 /micro L or greater than 15,000/micro L; hemoglobin concentration, under 8 g/dL; platelet count, under 100,000/micro L; aspartate aminotransferase or alanine aminotransferase, equal or greater than 100 IU/L; and serum albumin, under 2 g/dL)
14) Splenomegaly on computed tomography
15) Pregnancy
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shuzo |
| Middle name | |
| Last name | KOBAYASHI |
Organization
Shonan Kamakura General Hospital
Division name
Kidney Disease and Transplant Center
Zip code
247-8533
Address
1370-1 Okamoto, Kamakura-shi, Kanagawa-ken 247-8533, Japan
TEL
0467-46-1717
shuzo@shonankamakura.or.jp
Public contact
Name of contact person
| 1st name | Takayasu |
| Middle name | |
| Last name | OHTAKE |
Organization
Shonan Kamakura General Hospital
Division name
Kidney Disease and Transplant Center
Zip code
247-8533
Address
1370-1 Okamoto, Kamakura-shi, Kanagawa-ken 247-8533, Japan
TEL
0467-46-1717
Homepage URL
ohtake@shonankamakura.or.jp
Sponsor or person
Institute
Center for Clinical and Translational Science, Shonan Kamakura General Hospital, Tokushukai Medical Group.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Certified Committee of Shonan Kamakura General Hospital for Regenerative Medicine
Address
1370-1 Okamoto, Kamakura-shi, Kanagawa-ken 247-8533, Japan
Tel
0467-46-1717
rm_committee@shonankamakura.or.jp
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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 07 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
1
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
| 2019 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 16 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Please refer to the information in jRCT (jRCTb030190142) on and after November 27, 2019.
Management information
Registered date
| 2019 | Year | 07 | Month | 11 | Day |
Last modified on
| 2020 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042515
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
