Acute Ischemic StrokePhase 1/2J-REPAIRNCT04608838
A Randomized Placebo-controlled Multicenter Trial to Evaluate the Efficacy and Safety of JTR-161, Allogeneic Human Dental Pulp Stem Cell, in Patients With Acute Ischemic stRoke (J-REPAIR)
A Phase 1/2 study testing JTR-161 in people with Acute Ischemic Stroke, run by Teijin Pharma Limited at 1 site in Japan.
Trial summary
The objective of this study is to evaluate the safety and efficacy of a single intravenous administration of JTR-161 (allogeneic stem cell product derived from the dental pulp of healthy adult humans) to patients with acute ischemic stroke. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- JTR-161
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 1 siteJapan
- Study dates
- 30 Jan 2019to 24 Nov 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have ischemic strokes in the anterior circulation
- Patients whose mRS is 0 or 1 prior to the onset of ischemic stroke
- Patients whose NIHSS score of ≥5 to ≤20 at screening
- Patients who can be administered dosing solutions within 48 h of stroke onset
Who cannot join
- Patients who have new ischemic lesion in the cerebellum or brainstem
- Patients whose consciousness level drops severely
- Patients whose infarct area is widespread
- Patients who have a clinically significant hemorrhagic transformation
- Patients who had seizures after onset of ischemic stroke
- Patients who have medical history of a neurological event such as stroke or clinically significant head trauma within 180 days prior to giving informed consent
Show all 23Show fewer
- Patients who have poor blood pressure control
- Patients who have poor glycaemic control
- Patients who have one of the following complications
- Severe liver dysfunction
- Severe kidney dysfunction
- Severe heart failure
- Severe pulmonary dysfunction
- Patients who have severe infections
- Patients who have any neurological disorder affecting informed consent or study assessments
- Patients who have the malignant tumor, or medical history of malignant tumor within 2 years prior to the onset of ischemic stroke
- Patients who have a contraindication for MRI
- Patients who have thrombocytopenia
- Patients who have medical history of allergy to products derived from human tissues, bovine or porcine
- Patients who have medical history of allergy to streptomycin
- Patients who have undergone splenectomy in the past
- Patients who have a possibility of transient ischemic attack
- Patients who are scheduled to undergo revascularization (carotid endarterectomy, stent placement etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Exploratory, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate Safety and Efficacy of JTR-161 in Patients With Acute Ischemic Stroke
The objective of this study is to evaluate the safety and efficacy of a single intravenous administration of JTR-161 (allogeneic stem cell product derived from the dental pulp of healthy adult humans) to patients with acute ischemic stroke.
This study is comprised of 3 cohorts and conducted in the order of Cohort 1, Cohort 2 and Cohort 3.
Read more
Cohort 1 Arm-1: JTR-161, 1 × 10^8 cells/subject, 6 subjects Arm-2: Placebo, 2 subjects
The Data and Safety Monitoring Board (DSMB) and the Sponsor will decide whether Cohort 2 can be initiated or not.
Cohort 2 Arm-1: JTR-161, 3 × 10^8 cells/subject, 6 subjects Arm-2: Placebo, 2 subjects
DSMB and the Sponsor will decide whether Cohort 3 can be initiated or not and the dose of JTR-161 in Cohort 3.
Cohort 3 Arm-1: JTR-161, 1 × 10^8 cells/subject or 3 × 10^8 cells/subject, 30 subjects Arm-2: Placebo, 30 subjects
- Conditions
- Acute Ischemic Stroke
- Being tested
- JTR-161, Placebo
- Keywords
- Acute Ischemic Stroke
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JTR-161Biological
JTR-161 (1 or 3 × 10^8 cells/subject) will be suspended and administered in an intravenously infusion.
PlaceboBiological
Placebo will be suspended and administered in an intravenously infusion.
| Study group | Role | What they receive |
|---|---|---|
| JTR-161 | Experimental | Not described Receives: Biological: JTR-161 |
| Placebo | Placebo comparator | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of patients who achieved Excellent outcome (modified Rankin Scale [mRS] ≤1 and National Institutes of Health Stroke Scale [NIHSS] ≤1 and Barthel Index [BI] ≥95) on Day 91 in Cohort 3.
Measured: 91 days
Secondary outcomes (11)
Percentage of patients who achieved mRS ≤ 1 or mRS ≤ 2
Measured: 366 days
Percentage of patients who achieved BI ≥ 95
Measured: 366 days
Percentage of patients who achieved NIHSS ≤ 1, who achieved improvement of ≥ 75%, and who achieved improvement of ≥ 10 points
Measured: 91 days
Changes in EQ-5D-5L scores
The EuroQOL 5 dimension 5-level (EQ-5D-5L) consists of 2 parts: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1="no problems", 2="slight problems", 3="moderate problems", 4="severe problems" and 5="extreme problems".
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.
Measured: 366 days
Percentage of patients who achieved excellent outcome (mRS ≤ 1, NIHSS ≤ 1, and BI ≥ 95)
Measured: 91 days
Percentage of patients who showed overall improvement (mRS ≤ 2, NIHSS improvement of ≥ 75%, and BI ≥ 95)
Measured: 91 days
Incidence of Adverse events (signs and symptoms)
Measured: 366 days
Changes in Laboratory tests (hematology, blood chemistry, blood coagulation test, urinalysis)
Number of participants with clinical laboratory abnormalities for each parameter
- hematology Red blood cell count, Hemoglobin, Hematocrit, Platelet count, Leukocyte count, Leukocyte formula (neutrophils, lymphocytes, monocytes, eosinophils, basophils)
- blood chemistry Total protein, Albumin, Total bilirubin, Aspartate aminotransferase , Alanine aminotransferase, Alkaline phosphatase , Lactate dehydrogenase , γ-Glutamyltransferase, Blood urea nitrogen , Creatinine, Uric acid, Sodium, Potassium, Calcium, Chloride, Creatine kinase , C-reactive protein
- blood coagulation Prothrombin time (International normalized ratio) , Activated partial thromboplastin time
- urinalysis Urine Protein, Urine Glucose
Measured: 366 days
Changes in Vital signs (blood pressure [systolic/diastolic], pulse rate, body temperature)
Number of participants of the vital signs abnormalities for each parameter: blood pressure (mmHg), pulse rate (bpm) and body temperature (℃).
Measured: 366 days
Changes in Oxygen saturation (SpO2)
Measured: 366 days
Changes in findings of imaging examination by Magnetic Resonance Imaging (MRI) or Computed Tomography (CT).
Measured: 31 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start30 Jan 2019
- Primary completion15 Feb 2021
- Study completion24 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teijin Pharma Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04608838
- Sponsor's protocol ID
- JTR-161-201
- Acronym
- J-REPAIR
- Status last verified
- Jun 2022
- First submitted
- 8 Sep 2020
- Last updated
- 30 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Suda S, Nito C, Ihara M, Iguchi Y, Urabe T, Matsumaru Y, Sakai N, Kimura K; J- REPAIR trial group. Randomised placebo-controlled multicentre trial to evaluate the efficacy and safety of JTR-161, allogeneic human dental pulp stem cells, in patients with Acute Ischaemic stRoke (J-REPAIR). BMJ Open. 2022 May 24;12(5):e054269. doi: 10.1136/bmjopen-2021-054269.
PubMed 35613802
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate Safety and Efficacy of JTR-161 in Patients With Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT04608838
- Acronym / sponsor ID
- J-REPAIR / JTR-161-201
- Conditions
- Acute Ischemic Stroke
- Keywords
- Acute Ischemic Stroke
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Teijin Pharma LimitedIndustry (pharma, biotech, devices)
- Study start
- 30 Jan 2019 (actual)
- Primary completion
- 15 Feb 2021 (actual)
- Study completion
- 24 Nov 2021 (actual)
- First posted
- 29 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the safety and efficacy of a single intravenous administration of JTR-161 (allogeneic stem cell product derived from the dental pulp of healthy adult humans) to patients with acute ischemic stroke.
This study is comprised of 3 cohorts and conducted in the order of Cohort 1, Cohort 2 and Cohort 3.
Cohort 1 Arm-1: JTR-161, 1 × 10^8 cells/subject, 6 subjects Arm-2: Placebo, 2 subjects
The Data and Safety Monitoring Board (DSMB) and the Sponsor will decide whether Cohort 2 can be initiated or not.
Cohort 2 Arm-1: JTR-161, 3 × 10^8 cells/subject, 6 subjects Arm-2: Placebo, 2 subjects
DSMB and the Sponsor will decide whether Cohort 3 can be initiated or not and the dose of JTR-161 in Cohort 3.
Cohort 3 Arm-1: JTR-161, 1 × 10^8 cells/subject or 3 × 10^8 cells/subject, 30 subjects Arm-2: Placebo, 30 subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JTR-161 | Experimental | Biological: JTR-161 |
| Placebo | Placebo comparator | Biological: Placebo |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who have ischemic strokes in the anterior circulation
- Patients whose mRS is 0 or 1 prior to the onset of ischemic stroke
- Patients whose NIHSS score of ≥5 to ≤20 at screening
- Patients who can be administered dosing solutions within 48 h of stroke onset
Key exclusion criteria (23 listed)
- Patients who have new ischemic lesion in the cerebellum or brainstem
- Patients whose consciousness level drops severely
- Patients whose infarct area is widespread
- Patients who have a clinically significant hemorrhagic transformation
- Patients who had seizures after onset of ischemic stroke
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JTR-161JTR-161 (1 or 3 × 10^8 cells/subject) will be suspended and administered in an intravenously infusion. | Biological | JTR-161 |
| PlaceboPlacebo will be suspended and administered in an intravenously infusion. | Biological | Placebo |
Primary outcome
The percentage of patients who achieved Excellent outcome (modified Rankin Scale [mRS] ≤1 and National Institutes of Health Stroke Scale [NIHSS] ≤1 and Barthel Index [BI] ≥95) on Day 91 in Cohort 3.
Time frame: 91 days
11 secondary outcomes
Percentage of patients who achieved mRS ≤ 1 or mRS ≤ 2
Time frame: 366 days
Percentage of patients who achieved BI ≥ 95
Time frame: 366 days
Percentage of patients who achieved NIHSS ≤ 1, who achieved improvement of ≥ 75%, and who achieved improvement of ≥ 10 points
Time frame: 91 days
Changes in EQ-5D-5L scores
Time frame: 366 days
Percentage of patients who achieved excellent outcome (mRS ≤ 1, NIHSS ≤ 1, and BI ≥ 95)
Time frame: 91 days
Percentage of patients who showed overall improvement (mRS ≤ 2, NIHSS improvement of ≥ 75%, and BI ≥ 95)
Time frame: 91 days
Incidence of Adverse events (signs and symptoms)
Time frame: 366 days
Changes in Laboratory tests (hematology, blood chemistry, blood coagulation test, urinalysis)
Time frame: 366 days
Changes in Vital signs (blood pressure [systolic/diastolic], pulse rate, body temperature)
Time frame: 366 days
Changes in Oxygen saturation (SpO2)
Time frame: 366 days
Changes in findings of imaging examination by Magnetic Resonance Imaging (MRI) or Computed Tomography (CT).
Time frame: 31 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
- Derived from this study: PubMed 35613802Suda S, Nito C, Ihara M, Iguchi Y, Urabe T, Matsumaru Y, Sakai N, Kimura K; J- REPAIR trial group. Randomised placebo-controlled multicentre trial to evaluate the efficacy and safety of JTR-161, allogeneic human dental pulp stem cells, in patients with Acute Ischaemic stRoke (J-REPAIR). BMJ Open. 2022 May 24;12(5):e054269. doi: 10.1136/bmjopen-2021-054269.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing JTR-161 in people with Acute Ischemic Stroke, run by Teijin Pharma Limited at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of patients who achieved Excellent outcome (modified Rankin Scale [mRS] ≤1 and National Institutes of Health Stroke Scale [NIHSS] ≤1 and Barthel Index [BI] ≥95) on Day 91 in Cohort 3. (time frame: 91 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04608838, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2022.