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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026130
Receipt No. 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 2020/08/18

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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
Email 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
Email amiura0904@huhp.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital
Institute
Department

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
Email 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 No longer recruiting
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
2020 Year 08 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029942

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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