UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026130 |
|---|---|
| Receipt number | R000029942 |
| Scientific Title | Research on Advanced Intervention using Novel Bone marrOW stem cell (RAINBOW): Phase I, open-label, uncontrolled, dose-response trial of autologous bone marrow stromal cell transplantation in patients with acute ischemic stroke |
| Date of disclosure of the study information | 2017/02/22 |
| Last modified on | 2021/06/15 15:21:22 |
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Basic information
Public title
Research on Advanced Intervention using Novel Bone marrOW stem cell (RAINBOW): Phase I, open-label, uncontrolled, dose-response trial of autologous bone marrow stromal cell transplantation in patients with acute ischemic stroke
Acronym
RAINBOW trial
Scientific Title
Research on Advanced Intervention using Novel Bone marrOW stem cell (RAINBOW): Phase I, open-label, uncontrolled, dose-response trial of autologous bone marrow stromal cell transplantation in patients with acute ischemic stroke
Scientific Title:Acronym
RAINBOW trial
Region
| Japan |
Condition
Condition
acute ischemic stroke
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Safety and efficacy of HUNS001-01(BMSC) by stereotactic injection
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety of HUNS001-01 administration for 1 year after the intervention: frequency of Adverse Event (AE)
Key secondary outcomes
Safety of HUNS001-01 administration for 30 days after the intervention: frequency of Adverse Event (AE)
Safety of bone marrow aspiration: frequency of Adverse Event (AE)
Frequency of the defects of HUNS001-01 at manufacturing
Improvement of stroke symptoms for 1 year after the intervention using the following assessment scales:
National Institute of Health Stroke Scale (NIHSS)
modified Rankin Scale (mRS)
Functional Independence Measure (FIM)
Barthel Index
Fugl-Meyer Assessment
Improvement in lesion volume assessed by MRI analysis for 1 year after the intervention
Assessment of cell distribution using MRI
Assessment of possible functional shift for 1 year after the intervention using FDG-PET and IMZ-SPECT
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver | Other |
Interventions/Control_1
On the day when HUNS001-01 is manufactured, the cell product will be administered to the subject. A dose of 2 x 10^7 cells (400 micro L) will be administered in the low-dose group. HUNS001-01 is implanted using MRI stereotactic technique to define the target sites in the normal white matter around the lesion. The number of target sites is one or two in the low-dose group, and two or three in the high-dose group. The subject has a one or two burr-hole craniotomy under local anesthesia and sedation. Using 2.1-mm outer diameter stereotactic cannula, 200 to 400 micro L of the product is injected over a period of 5 min at each site. The cannula is removed after 5 min after finishing the injection at each site. In the perioperative period, all subjects take fosphenytoin sodium hydrate to prevent epileptic seizure due to the procedure.
Interventions/Control_2
On the day when HUNS001-01 is manufactured, the cell product will be administered to the subject. A dose of 5 x 10^7 cells (1,000 micro L) will be administered in the high-dose group. HUNS001-01 is implanted using MRI stereotactic technique to define the target sites in the normal white matter around the lesion. The number of target sites is one or two in the low-dose group, and two or three in the high-dose group. The subject has a one or two burr-hole craniotomy under local anesthesia and sedation. Using 2.1-mm outer diameter stereotactic cannula, 200 to 500 micro L of the product is injected over a period of 5 min at each site. The cannula is removed after 5 min after finishing the injection at each site. In the perioperative period, all subjects take fosphenytoin sodium hydrate to prevent epileptic seizure due to the procedure.
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
First screening; 14 days after the onset of stroke
1) Male or female subjects between 20 and 79 years old
2) Informed consent within 14 days after the onset
3) Clinical diagnosis of cerebral ischemic stroke on the internal carotid arterial region
4) Subjects with 0 or 1 in modified Rankin Scale (mRS) before the onset
5) Subjects who can have an informed consent; if insufficiently, legal representative is needed
6) Subjects with moderate or severe neurological symptoms; National Institute of Health Stroke Scale (NIHSS) more than 6, (however, the partial score in both `5. Motor Arm' and `6. Motor Leg' are more than 6)
Second screening; 7 days before the administration
1) HUNS001-01 is available within 74 days after the onset
2) Subjects with moderate or severe neurological deficit; mRS>=3
Key exclusion criteria
First screening
1) Occurrence of a severe hemorrhagic transformation of ischemic stroke
2) Subjects with deep coma or coma evaluated by Japan Coma Scale (JCS; 300 or 200)
3) Severe anemia (hemoglobin<10.0 g/dL) or thrombocytopenia (platelet count <100,000/mm^3)
4) Severe heart disease (e.g. ischemic heart disease, heart failure)
5) Significant abnormal laboratory tests;
a. >3 x ULN for alanine aminotransferase or aspartate aminotransferase
b. >1.5 x ULN for total bilirubin
c. >1.5 x ULN for serum creatinine
6) Uncontrolled hypertension, despite antihypertensive therapy
7) History of malignancy of any type
8) Carriers of infectious disease as follows: Syphilis, hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV)-1/2, human T cell leukemia virus (HTLV)-1, or parvovirus B19
9) Subjects who are during pregnancy or want to have children
10) Lactating women
11) Fertile Women who are unable to practice contraception
12) History of seizure or administration of any antiepileptic drugs
13) Contraindication for taking fosphenytoin sodium hydrate
14) Serious allergy to any possible residues in the test product (e.g. any biomaterials used in manufacturing process, gentamicin sulfate, ferucarbotran) or any agents used for the administration of the test product or any inspections during the trial
15) Contraindication for MRI (e.g. a pacemaker, metallic artificial heart valves, an implantable cardioverter defibrillator)
16)Subjects who participate in other clinical trial within 90 days before enrollment.
17) Subjects who are improper on the basis of the judgement by primary investigator or other investigators.
Second screening
1-6) The same criteria at first screening
7) Subjects who are improper on the basis of the judgement by primary investigator or other investigators
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Masahito |
| Middle name | |
| Last name | Kawabori |
Organization
Hokkaido University Hospital
Division name
Department of neurosurgery
Zip code
0808638
Address
Kita 15, Nishi 7, Kita-ku, Sapporo, Hokkaido, Japan060-8638
TEL
011-706-5987
kawabori@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Arisa |
| Middle name | |
| Last name | Miura |
Organization
Hokkaido University Hospital
Division name
Clinical Research and Medical Innovation Center
Zip code
0808638
Address
Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido, Japan060-8648
TEL
011-706-7735
Homepage URL
amiura0904@huhp.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University Hospital
Address
Kita 15, Nishi 7, Kita-ku, Sapporo, Hokkaido, Japan060-8638
Tel
011-706-5987
kawabori@med.hokudai.ac.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
| 2017 | Year | 02 | Month | 22 | 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
7
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
Completed
Date of protocol fixation
| 2016 | Year | 12 | Month | 22 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 20 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2020 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2020 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 14 | Day |
Last modified on
| 2021 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029942
