Unique ID issued by UMIN | UMIN000038810 |
---|---|
Receipt number | R000044251 |
Scientific Title | clinical study to evaluate the safety o f intra-bone marrow cotransplantation o f adipose -derived mesenchymal stromal cells and cord blood cells |
Date of disclosure of the study information | 2019/12/06 |
Last modified on | 2019/12/06 16:16:13 |
safety study on co -transplantation o f adipose
-derived mesenchymal stromal cell and cord
blood cells
iCTAC
clinical study to evaluate the safety o f intra-bone marrow cotransplantation o f adipose -derived mesenchymal stromal cells and cord blood cells
iCTAC
Japan |
hematological disorders to be applied to cord blood cell transplantation
Hematology and clinical oncology |
Malignancy
NO
To evaluate safety of co -transpantation of adipose
-derived mesenchymal stromal cell and cord
blood cells in the setting of cord blood cell transplantation.
Safety
Confirmatory
Phase I
Adverse events related to bone marrow injection of mesenchymal stromal cells within 14 days after transplantation, other adverse events, death and project withdrawal related to adverse event.
1. engraftment rate , time for recovery of blood cell counts
2. adverse events up to 28 days after transplantation.
3. incidence and severity o f acute GVHD.
4. incidence and severity o f chronic GVHD.
5. treatment-related mortality at day 100 and
1year after transplantation
6. recurrence rate o f the disease at 1 year after transplantation
7. survival rate and disease free survival up
to 1 year after trans plantation.
8. incidence of infection
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
NO
NO
Institution is not considered as adjustment factor.
NO
No need to know
1
Treatment
Other |
intra bone marrow of adipose-derived mesenchymal stromal cells and cord blood cells
20 | years-old | <= |
70 | years-old | >= |
Male and Female
1. Patients with hematological disorders to be applied to cord blood cell transplantation.
2. Patient aged from 20 to 70 years
3. The disease is under complete remission (except for MDS).
4. Patients undergoing cord blood trans plantation.
5. Patients with agreements with the documents of this study.
6. Performance status is below 2.
7. Cord blood is available from cord blood center.
8. Patient with favorable organ functions .
ejection fraction > 40%
% F EV1.0 > =60 and % VC >= 50
AST / ALT < 5 X ULN
serum creatinine < 3 X ULN
1. Patients with HIV infection.
2. Patients with treatment o f Gemtuzumab ozogamicin (within 6 mo nth).
3. Patients with pregnancy, breast feeding or possibility o f pregnancy.
4. Patients with uncontrollable mental illness .
5. Patients with treatment-resistant infection.
6. Patients with drug allergy to wards anti-cancer drug s or immunosuppressants .
7. Patients who had another transplantation within 12 months .
8. Other conditions considered not suitable for the study by doctors .
9
1st name | Takayuki |
Middle name | |
Last name | Nakayama |
Aichi Medical University Hospital
Department of Clinical Laboratory
480-1195
1-1, Karimata, Yazako, Nagakute, Aichi, Japan
0561-62-3311
tnaka@aichi-med-u.ac.jp
1st name | Hidefumi |
Middle name | |
Last name | Kato |
Aichi Medical University Hospital
Department of Blood Transfusion and Cell Therapy
480-1195
1-1, Karimata, Yazako, Nagakute, Aichi, Japan
0561-62-3311
hkato@aichi-med-u.ac.jp
Aichi Medical University
Aichi Medical University
Self funding
None
National Hospital Organization Certified Special Committee for Regenerative Medicine
4-1-1, Sannomaru, Nakaku, Nagoya, Aichi, Aichi, Japan
052-951-1111
311-rmr@nnh.hosp.go.jp
YES
R2017-001
NA8170001
愛知医科大学病院
2019 | Year | 12 | Month | 06 | Day |
Unpublished
Enrolling by invitation
2018 | Year | 09 | Month | 21 | Day |
2018 | Year | 02 | Month | 09 | Day |
2019 | Year | 11 | Month | 27 | Day |
2023 | Year | 12 | Month | 02 | Day |
2019 | Year | 12 | Month | 06 | Day |
2019 | Year | 12 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044251
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |