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

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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name