StrokePhase 1/2AMETISNCT01468064
Autologous Bone Marrow Stromal Cell and Endothelial Progenitor Cell Transplantation in Ischemic Stroke
A Phase 1/2 study testing Autologous BMSCs transplantation and Autologous EPCs transplantation in people with Stroke and Infarction, Middle Cerebral Artery, run by Southern Medical University, China at 1 site in China.
Trial summary
The purpose of this study is to evaluate the feasibility, efficacy, and safety of autologous transplantation of ex vivo expanded bone marrow stromal cells (BMSCs)and endothelial progenitor cells (EPCs) for treatment of patients with ischemic stroke. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Infarction, Middle Cerebral Artery
- What is being tested?
- Autologous BMSCs transplantation and Autologous EPCs transplantation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Nov 2011to Mar 2017
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 to 80 years, within 7 days of the onset of symptoms
- Ischemic lesion within the MCA territory as assessed using diffusion-weighted imaging (DWI)
- The National Institutes of Health Stroke Scale (NIHSS) ≥ 7 at day 7 after the onset
- Signed informed consent
Who cannot join
- Lacunar syndrome
- Diagnosis other than ischemic stroke(eg. Intracranial hemorrhage or Intracranial tumor)
- Hematological causes of stroke
- Severe respiratory, hepatic, or renal disorders
- Presence of severe febrile illness or viral diseases
- Malignant diseases
Show all 9Show fewer
- Presence of autoimmune diseases
- Positive response of penicillin skin test, or multiple drug allergies
- Breast-feeding or pregnant women
Trial locations and contacts
1 site in 1 country.
China1 site
Zhujiang Hospital, Southern Medical University
Guangzhou, Guangdong, 510282
About this study
Official title: Autologous Bone Marrow Stromal Cell and Endothelial Progenitor Cell Transplantation in Patients With Ischemic Stroke: a Randomized Controlled Trial
The purpose of this study is to evaluate the feasibility, efficacy, and safety of autologous transplantation of ex vivo expanded bone marrow stromal cells (BMSCs)and endothelial progenitor cells (EPCs) for treatment of patients with ischemic stroke.
Read the detailed description
This study is a multi-center, single-blind, randomized, parallel controlled trail. Patients with acute cerebral infarcts within the middle cerebral arterial territory and with severe neurological deficits will be enrolled and randomly allocated into 3 groups: autologous BMSCs transplantation group, autologous EPCs transplantation group and Placebo control group. Randomization codes were established by the study statistician and were revealed only to the stem cell laboratory technician responsible for separating the cells into aliquots or preparing the placebo material. All patients will undergo a Bone Marrow aspiration procedure at 7 days after symptom onset. BMSCs and EPCs will be expanded ex vivo and then intravenously infused into own body, respectively. The control group will not receive cell therapy. Observe will followed for up to 1 year after the onset. Neurological score, neuroimaging, mortality of any cause, side effects, and new-onset comorbidities will be monitored and compared between each groups.
- Conditions
- Stroke, Infarction, Middle Cerebral Artery
- Being tested
- Autologous BMSCs transplantation, Autologous EPCs transplantation, IV infusion of placebo
- Keywords
- Central Nervous System Diseases, Stroke, Infarction, Middle Cerebral Artery, Cerebral Infarction, Cerebrovascular Accident, Stem Cell Transplantation, Mesenchymal Stem Cell Transplantation, Bone marrow stromal cells, Mesenchymal Stem Cells, Endothelial progenitor cells, Adult Stem Cells, Cell Therapy
- Medical subject headings
- Stroke, Infarction, Middle Cerebral Artery, Central Nervous System Diseases, Cerebral Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous BMSCs transplantationGenetic
Also called Autologous Bone marrow stromal cells transplantation, Autologous Mesenchymal stem cells transplantation
The first transplantation: 2.5 million cells per kg autologous BMSCs suspended in 100 ml saline plus 5% autologous serum are infused intravenously approximately 4 weeks after bone marrow aspiration.
The second transplantation: the same amount of cells are again transplanted approximately 1 weeks after initial boosting.
Autologous EPCs transplantationGenetic
Also called Autologous endothelial progenitor cells transplantation
The first transplantation: 2.5 million cells per kg autologous EPCs suspended in 100 ml saline plus 5% autologous serum are infused intravenously approximately 4 weeks after bone marrow aspiration.
The second transplantation: the same amount of cells are again transplanted approximately 1 weeks after initial boosting.
IV infusion of placeboGenetic
Also called Placebo control group
IV infusion of saline plus 5% autologous serum.
| Study group | Role | What they receive |
|---|---|---|
| BMSCs group | Experimental | Not described Receives: Genetic: Autologous BMSCs transplantation |
| EPCs group | Experimental | Not described Receives: Genetic: Autologous EPCs transplantation |
| Control group | Placebo comparator | Not described Receives: Genetic: IV infusion of placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events after infusion of BMSCs or EPCs.
Measured: 1 year
Secondary outcomes (1)
Changes in functional outcomes measured by the modified Rankin Scale (mRS) and the Barthel index (BI).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionDec 2015
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southern Medical University, China
- Sponsor type
- University, hospital or other
- Collaborators
- The Second People's Hospital of Nanhai District of Foshan, The First People's Hospital of Haizhu District Guangzhou, Cellonis Biotechnology Co. Ltd.
- Responsible party
- Principal investigator, Zhen-Zhou Chen, Southern Medical University, China
- Investigators
- Zhenzhou Chen, MD., phD., Principal investigator, Department of Neurosurgery, Zhujiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01468064
- Sponsor's protocol ID
- ZJH-001
- Other IDs
- 2011A030400007
- Acronym
- AMETIS
- Status last verified
- Apr 2021
- First submitted
- 2 Nov 2011
- Last updated
- 2 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee JS, Hong JM, Moon GJ, Lee PH, Ahn YH, Bang OY; STARTING collaborators. A long-term follow-up study of intravenous autologous mesenchymal stem cell transplantation in patients with ischemic stroke. Stem Cells. 2010 Jun;28(6):1099-106. doi: 10.1002/stem.430.
PubMed 20506226Bang OY, Lee JS, Lee PH, Lee G. Autologous mesenchymal stem cell transplantation in stroke patients. Ann Neurol. 2005 Jun;57(6):874-82. doi: 10.1002/ana.20501.
PubMed 15929052Fang J, Guo Y, Tan S, Li Z, Xie H, Chen P, Wang K, He Z, He P, Ke Y, Jiang X, Chen Z. Autologous Endothelial Progenitor Cells Transplantation for Acute Ischemic Stroke: A 4-Year Follow-Up Study. Stem Cells Transl Med. 2019 Jan;8(1):14-21. doi: 10.1002/sctm.18-0012. Epub 2018 Aug 29.
PubMed 30156755
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Bone Marrow Stromal Cell and Endothelial Progenitor Cell Transplantation in Patients With Ischemic Stroke: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01468064
- Acronym / sponsor ID
- AMETIS / ZJH-001
- Conditions
- Stroke, Infarction, Middle Cerebral Artery
- Keywords
- Central Nervous System Diseases, Stroke, Infarction, Middle Cerebral Artery, Cerebral Infarction, Cerebrovascular Accident, Stem Cell Transplantation, Mesenchymal Stem Cell Transplantation, Bone marrow stromal cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Southern Medical University, ChinaUniversity, hospital or other
- Collaborators
- The Second People's Hospital of Nanhai District of Foshan, The First People's Hospital of Haizhu District Guangzhou, Cellonis Biotechnology Co. Ltd.
- Study start
- Nov 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 9 Nov 2011 (estimated)
- 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 purpose of this study is to evaluate the feasibility, efficacy, and safety of autologous transplantation of ex vivo expanded bone marrow stromal cells (BMSCs)and endothelial progenitor cells (EPCs) for treatment of patients with ischemic stroke.
Detailed description
This study is a multi-center, single-blind, randomized, parallel controlled trail. Patients with acute cerebral infarcts within the middle cerebral arterial territory and with severe neurological deficits will be enrolled and randomly allocated into 3 groups: autologous BMSCs transplantation group, autologous EPCs transplantation group and Placebo control group. Randomization codes were established by the study statistician and were revealed only to the stem cell laboratory technician responsible for separating the cells into aliquots or preparing the placebo material. All patients will undergo a Bone Marrow aspiration procedure at 7 days after symptom onset. BMSCs and EPCs will be expanded ex vivo and then intravenously infused into own body, respectively. The control group will not receive cell therapy. Observe will followed for up to 1 year after the onset. Neurological score, neuroimaging, mortality of any cause, side effects, and new-onset comorbidities will be monitored and compared between each groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BMSCs group | Experimental | Genetic: Autologous BMSCs transplantation |
| EPCs group | Experimental | Genetic: Autologous EPCs transplantation |
| Control group | Placebo comparator | Genetic: IV infusion of placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18 to 80 years, within 7 days of the onset of symptoms
- Ischemic lesion within the MCA territory as assessed using diffusion-weighted imaging (DWI)
- The National Institutes of Health Stroke Scale (NIHSS) ≥ 7 at day 7 after the onset
- Signed informed consent
Key exclusion criteria (9 listed)
- Lacunar syndrome
- Diagnosis other than ischemic stroke(eg. Intracranial hemorrhage or Intracranial tumor)
- Hematological causes of stroke
- Severe respiratory, hepatic, or renal disorders
- Presence of severe febrile illness or viral diseases
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 |
|---|---|---|
| Autologous BMSCs transplantationAlso: Autologous Bone marrow stromal cells transplantation, Autologous Mesenchymal stem cells transplantationThe first transplantation: 2.5 million cells per kg autologous BMSCs suspended in 100 ml saline plus 5% autologous serum are infused intravenously approximately 4 weeks after bone marrow aspiration. The second transplantation: the same amount of cells are again transplanted approximately 1 weeks after initial boosting. | Genetic | BMSCs group |
| Autologous EPCs transplantationAlso: Autologous endothelial progenitor cells transplantationThe first transplantation: 2.5 million cells per kg autologous EPCs suspended in 100 ml saline plus 5% autologous serum are infused intravenously approximately 4 weeks after bone marrow aspiration. The second transplantation: the same amount of cells are again transplanted approximately 1 weeks after initial boosting. | Genetic | EPCs group |
| IV infusion of placeboAlso: Placebo control groupIV infusion of saline plus 5% autologous serum. | Genetic | Control group |
Primary outcome
Number of adverse events after infusion of BMSCs or EPCs.
Time frame: 1 year
1 secondary outcome
Changes in functional outcomes measured by the modified Rankin Scale (mRS) and the Barthel index (BI).
Time frame: 1 year
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 2 Apr 2021.
- Background: PubMed 20506226Lee JS, Hong JM, Moon GJ, Lee PH, Ahn YH, Bang OY; STARTING collaborators. A long-term follow-up study of intravenous autologous mesenchymal stem cell transplantation in patients with ischemic stroke. Stem Cells. 2010 Jun;28(6):1099-106. doi: 10.1002/stem.430.
- Background: PubMed 15929052Bang OY, Lee JS, Lee PH, Lee G. Autologous mesenchymal stem cell transplantation in stroke patients. Ann Neurol. 2005 Jun;57(6):874-82. doi: 10.1002/ana.20501.
- Derived from this study: PubMed 30156755Fang J, Guo Y, Tan S, Li Z, Xie H, Chen P, Wang K, He Z, He P, Ke Y, Jiang X, Chen Z. Autologous Endothelial Progenitor Cells Transplantation for Acute Ischemic Stroke: A 4-Year Follow-Up Study. Stem Cells Transl Med. 2019 Jan;8(1):14-21. doi: 10.1002/sctm.18-0012. Epub 2018 Aug 29.
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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.
Zhenzhou Chen, MD., phD. principal investigator
Department of Neurosurgery, Zhujiang Hospital
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 Autologous BMSCs transplantation and Autologous EPCs transplantation in people with Stroke and Infarction, Middle Cerebral Artery, run by Southern Medical University, China at 1 site in China.
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 9 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 2 Apr 2021. 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 China. 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?
Number of adverse events after infusion of BMSCs or EPCs. (time frame: 1 year). 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 NCT01468064, which also lists 3 linked publications.
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 2 Apr 2021.