Ischemic StrokePhase 2AMASCIS-02NCT04280003
Allogeneic Adipose Tissue-derived Mesenchymal Stem Cells in Ischemic Stroke
A Phase 2 study testing Alogenic adipose tissue-derived stem cells in people with Ischemic Stroke and Adipose Tissue-derived Stem Cell, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
Trial summary
This is a multicenter, doble blind, placebo controlled clinical trial to asses de safety and efficacy of intravenous administration of alogenic adipose tissue-derived mesenchymal stem cells in the first four days from acute ischemic stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Adipose Tissue-derived Stem Cell, Functional Status
- What is being tested?
- Alogenic adipose tissue-derived stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 20 Jan 2021to 15 Jul 2023
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ischemic stroke patients > 18 years old
- Patients must be able to be treated within the first 4 days (+/- 1) from acute stroke symptoms onset. If the time of symptom onset is unknown, this shall refer to the last time the patient was observed as asymptomatic.
- A computed tomography (CT) or magnetic resonance imaging (MRI) scan compatible with the clinical diagnosis of acute non-lacunar IS in the region of the middle cerebral artery (with cortical or subcortical involvement).
- A score on the National Institute of Health Stroke Scale (NIHSS) of 8-20, with at least two of these points in sections 5 and 6 (motor deficit) at the time of inclusion. NIHSS evaluation for screening of these patients will take place after finalization of reperfusion therapies (if they have been performed) providing that the clinical condition of the patient is stable with no prevision of immediate recovery. A measurable focal neurologic disabilty must persist to the time of treatment.
- A prestroke score on the Modified Rankin Scale (mRS) ≤1 (no significant disability).
- Female subjects non-child bearing potential. Female subjects who are of non-childbearing potential are defined as meeting at least 1 of the following criteria:
Show all 9Show fewer
- Have undergone a documented hysterectomy and/or bilateral oophorectomy; Have medically confirmed ovarian failure; or Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause.
- Female subjects of child-bearing potential need a negative pregnancy test and must agree to use adequate contraception for the duration of the study (from screening through the final of the study). The following types of contraception are considered adequate provided they are locally authorized for use: oral, transdermal, or injectable (depot) estrogen and/or progestogen, selective estrogen receptor modulator therapy, intrauterine contraceptive device, double barrier method (e.g., condom and diaphragm or spermicidal gel) or vasectomy.
- Signed informed consent
Who cannot join
- Comatose patients; patients with a score of 2 or more on item 1a of the NIHSS related to the degree of awareness.
- Evidence on neuroimaging of brain tumour, cerebral oedema with midline shift and a clinically significant compression of ventricles, cerebellar or brainstem infarction and intraventricular, intracerebral or subarachnoid haemorrhage. Small petechial haemorrhages are not exclusion criteria.
- Current drug or alcohol use or dependence
- Active infectious disease, including human immunodeficiency virus, hepatitis B, and hepatitis C. A controlled infection is not an exclusion criterion.
- Pre-existing dementia.
- A health status, any clinical condition (eg, short life expectancy, and coexisting disease or a surgical or endovascular planned procedure) or other characteristic that precludes appropriate diagnosis, treatment, or follow-up in the trial.
- Patients who are participating in another clinical trial.
- Inability or unwillingness of the individual or their legal guardian/representative to provide written informed consent.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario La Paz
Madrid, 28046
Blanca Fuentes Gimeno, 917277444, blanca.fuentes@salud.madrid.org
Elena de Celis Ruiz, 917277444, elena.decelis@salud.madrid.org
About this study
Official title: Allogeneic Adipose Tissue-derived Mesenchymal Stem Cells in Ischemic Stroke. A Phase IIB Multicenter Double Blind Placebo Controlled Clinical Trial
This is a multicenter, doble blind, placebo controlled clinical trial to asses de safety and efficacy of intravenous administration of alogenic adipose tissue-derived mesenchymal stem cells in the first four days from acute ischemic stroke.
Read the detailed description
Two spanish hospitals with teams experienced in stroke management will participate in this study, recruiting a total of 30 patients between them both. After confirming that patients fulfill the inclusion criteria and none of the exclusion criteria, informed consent will be signed and randomization will take place (1:1). There are two different groups of treatment; the first group will be treated with intravenous alogenic adipose tissue-derived stem cells (at a concentration of one million cells per kg) within the first four days from stroke onset, the second group will be treated will an intravenous placebo solution. Follow-up will last for 24 months during which safety issues such as adverse events and neurological and systemic complications will be assessed at 24 hours, 7 days and 3, 6, 12,18 and 24 months after treatment. Neurological disability using the modified Rankin Scale and National Institute of Health Stroke Scale will also be registered in every scheduled visit. Biochemical markers of tissue repair (GM-CSF, BDNF, VEGF, TGF-1, GFAP, MBP, MMP-3) as well as extracellular vesicles will be extracted on baseline visit as well as 7 days and 3 months after treatment.
- Being tested
- Alogenic adipose tissue-derived stem cells, Placebo solution
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alogenic adipose tissue-derived stem cellsOther
Concentration of the cells: 10 million cells / ml
Placebo solutionDrug
Placebo intravenous solution, same appearance stem cells solution
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | 15 patients will receive intravenous alogenic adipose tissue-derived stem cells in a single dose of one million cells per kg. Receives: Other: Alogenic adipose tissue-derived stem cells |
| Placebo group | Placebo comparator | 15 patients will receive a single intravenous placebo solution with the same appearance as the treatment group. Receives: Drug: Placebo solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of administration of adipose tissue-derived mesenchymal stem cells measured as reported adverse events
Adverse events reported spontaneously or in response to questions not addressed.
Measured: Up to 24 months after treatment or placebo administration
Safety of administration of adipose tissue-derived mesenchymal stem cells measured as neurological o systemic complications
Neurological or systemic complications
Measured: Up to 24 months after treatment or placebo administration
Secondary outcomes (3)
Efficacy of administration of adipose tissue-derived mesenchymal stem cells measured by the Modified Rankin Scale
Modified Rankin Scale (mRS): success is considered when the patient obtains a score of 0-3, and failure include scores of 4 to 6 at months 3,6,12 and 24. An additional exploratorry efficacy analysis of mRS shift at months 3,6,12 and 24 will also be made.
Measured: Up to 24 months after treatment or placebo administration
Efficacy of administration of adipose tissue-derived mesenchymal stem cells measured by the NIHSS
National Institute of Health Stroke Scale. It will be measured at all scheluded visits. Success is defined as an improvement of 75% or more from baseline. An additional exploratory analysis will look for differences in the distribution of median (IQR) and in the frequency of NIHSS ≤ 1between groups.
Measured: Up to 24 months after treatment or placebo administration
Efficacy of administration of adipose tissue-derived mesenchymal stem cells measuring blood brain repair biomarkers
Brain repair biomarkers in blood samples (GM-CSF, PDGF-BB, BDNF, VEGF, TGF-1, GFAP, MBP, MMP-3 and extracelular vesicles) measured at baseline, day 7 and mnth 3 after treatment or placebo administration.
Measured: Up to 3 months after treatment or placebo administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start20 Jan 2021
- Primary completion15 Jul 2023 (estimated)
- Study completion15 Jul 2023 (estimated)
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 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two different treatment grupos; intravenous alogenic adipose tissue-derived mesenchymal stem cells or intravenous placebo solution
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04280003
- Sponsor's protocol ID
- AMASCIS - 02
- Acronym
- AMASCIS-02
- Status last verified
- May 2022
- First submitted
- 6 Aug 2019
- Last updated
- 30 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available from the corresponding author on reasonable request, considered compliant General Data Protection Regulation and the data-sharing agreement is approved by the relevant Spanish authorities. Upon study finalization, anonymized individual patient data will be available on a public repertoire of the Community of Madrid.
Publications
de Celis-Ruiz E, Fuentes B, Moniche F, Montaner J, Borobia AM, Gutierrez-Fernandez M, Diez-Tejedor E. Allogeneic adipose tissue-derived mesenchymal stem cells in ischaemic stroke (AMASCIS-02): a phase IIb, multicentre, double-blind, placebo-controlled clinical trial protocol. BMJ Open. 2021 Aug 9;11(8):e051790. doi: 10.1136/bmjopen-2021-051790.
PubMed 34373315
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogeneic Adipose Tissue-derived Mesenchymal Stem Cells in Ischemic Stroke. A Phase IIB Multicenter Double Blind Placebo Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04280003
- Acronym / sponsor ID
- AMASCIS-02 / AMASCIS - 02
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 15 Jul 2023 (estimated)
- Study completion
- 15 Jul 2023 (estimated)
- First posted
- 21 Feb 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.
This is a multicenter, doble blind, placebo controlled clinical trial to asses de safety and efficacy of intravenous administration of alogenic adipose tissue-derived mesenchymal stem cells in the first four days from acute ischemic stroke.
Detailed description
Two spanish hospitals with teams experienced in stroke management will participate in this study, recruiting a total of 30 patients between them both. After confirming that patients fulfill the inclusion criteria and none of the exclusion criteria, informed consent will be signed and randomization will take place (1:1). There are two different groups of treatment; the first group will be treated with intravenous alogenic adipose tissue-derived stem cells (at a concentration of one million cells per kg) within the first four days from stroke onset, the second group will be treated will an intravenous placebo solution. Follow-up will last for 24 months during which safety issues such as adverse events and neurological and systemic complications will be assessed at 24 hours, 7 days and 3, 6, 12,18 and 24 months after treatment. Neurological disability using the modified Rankin Scale and National Institute of Health Stroke Scale will also be registered in every scheduled visit. Biochemical markers of tissue repair (GM-CSF, BDNF, VEGF, TGF-1, GFAP, MBP, MMP-3) as well as extracellular vesicles will be extracted on baseline visit as well as 7 days and 3 months after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two different treatment grupos; intravenous alogenic adipose tissue-derived mesenchymal stem cells or intravenous placebo solution
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Other: Alogenic adipose tissue-derived stem cells15 patients will receive intravenous alogenic adipose tissue-derived stem cells in a single dose of one million cells per kg. |
| Placebo group | Placebo comparator | Drug: Placebo solution15 patients will receive a single intravenous placebo solution with the same appearance as the treatment group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Ischemic stroke patients > 18 years old
- Patients must be able to be treated within the first 4 days (+/- 1) from acute stroke symptoms onset. If the time of symptom onset is unknown, this shall refer to the last time the patient was observed as asymptomatic.
- A computed tomography (CT) or magnetic resonance imaging (MRI) scan compatible with the clinical diagnosis of acute non-lacunar IS in the region of the middle cerebral artery (with cortical or subcortical involvement).
- A score on the National Institute of Health Stroke Scale (NIHSS) of 8-20, with at least two of these points in sections 5 and 6 (motor deficit) at the time of inclusion. NIHSS evaluation for screening of these patients will take place after finalization of reperfusion therapies (if they have been performed) providing that the clinical condition of the patient is stable with no prevision of immediate recovery. A measurable focal neurologic disabilty must persist to the time of treatment.
- A prestroke score on the Modified Rankin Scale (mRS) ≤1 (no significant disability).
Key exclusion criteria (8 listed)
- Comatose patients; patients with a score of 2 or more on item 1a of the NIHSS related to the degree of awareness.
- Evidence on neuroimaging of brain tumour, cerebral oedema with midline shift and a clinically significant compression of ventricles, cerebellar or brainstem infarction and intraventricular, intracerebral or subarachnoid haemorrhage. Small petechial haemorrhages are not exclusion criteria.
- Current drug or alcohol use or dependence
- Active infectious disease, including human immunodeficiency virus, hepatitis B, and hepatitis C. A controlled infection is not an exclusion criterion.
- Pre-existing dementia.
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 |
|---|---|---|
| Alogenic adipose tissue-derived stem cellsConcentration of the cells: 10 million cells / ml | Other | Treatment group |
| Placebo solutionPlacebo intravenous solution, same appearance stem cells solution | Drug | Placebo group |
Primary outcome
Safety of administration of adipose tissue-derived mesenchymal stem cells measured as reported adverse events
Time frame: Up to 24 months after treatment or placebo administration
Adverse events reported spontaneously or in response to questions not addressed.
Safety of administration of adipose tissue-derived mesenchymal stem cells measured as neurological o systemic complications
Time frame: Up to 24 months after treatment or placebo administration
Neurological or systemic complications
3 secondary outcomes
Efficacy of administration of adipose tissue-derived mesenchymal stem cells measured by the Modified Rankin Scale
Time frame: Up to 24 months after treatment or placebo administration
Efficacy of administration of adipose tissue-derived mesenchymal stem cells measured by the NIHSS
Time frame: Up to 24 months after treatment or placebo administration
Efficacy of administration of adipose tissue-derived mesenchymal stem cells measuring blood brain repair biomarkers
Time frame: Up to 3 months after treatment or placebo administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2023.
- Background: PubMed 34373315de Celis-Ruiz E, Fuentes B, Moniche F, Montaner J, Borobia AM, Gutierrez-Fernandez M, Diez-Tejedor E. Allogeneic adipose tissue-derived mesenchymal stem cells in ischaemic stroke (AMASCIS-02): a phase IIb, multicentre, double-blind, placebo-controlled clinical trial protocol. BMJ Open. 2021 Aug 9;11(8):e051790. doi: 10.1136/bmjopen-2021-051790.
- Individual participant dataSharing planned: Yes. Data will be available from the corresponding author on reasonable request, considered compliant General Data Protection Regulation and the data-sharing agreement is approved by the relevant Spanish authorities. Upon study finalization, anonymized individual patient data will be available on a public repertoire of the Community of Madrid.
Related trials for Ischemic Stroke
Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
Ischemic Stroke
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingPhase 3
Probucol for Symptomatic Intracranial and Extracranial Artery Stenosis
Ischemic Stroke, TIA
Recruiting
MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System
Paralysis; Quadriplegic, Quadraplegia
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Alogenic adipose tissue-derived stem cells in people with Ischemic Stroke and Adipose Tissue-derived Stem Cell, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
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 9 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 30 May 2023. 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 Spain. 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 phase mean?
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Blanca Fuentes Gimeno (917277444, blanca.fuentes@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of administration of adipose tissue-derived mesenchymal stem cells measured as reported adverse events (time frame: Up to 24 months after treatment or placebo administration). The study lists 2 primary outcomes in all. 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 NCT04280003, 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 May 2023.