IschemiaPhase 2ISISNCT00875654
Intravenous Stem Cells After Ischemic Stroke
A Phase 2 study testing Autologous mesenchymal stem cells in people with Ischemia and Stroke, run by University Hospital, Grenoble at 3 sites in France.
Trial summary
The main objective of the study is to evaluate feasibility and tolerance of the intravenous injection of autologous mesenchymal stem cells for patients presenting an ischemic stroke (less than 6 weeks). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- What is being tested?
- Autologous mesenchymal stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 3 sitesFrance
- Study dates
- Aug 2010to 20 Oct 2017
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- right or left carotid ischemic stroke in the 14 previous days, confirmed by MRI.
- Persistent neurological deficit (NIHSS >=7).
- Optimal medical treatment(antithrombotics, antihypertensive, statins).
- General state compatible with a program of functional rehabilitation.
Who cannot join
- Severe extensive stroke implying vital prognosis.
- Severe persistent neurological deficit (NIHSS > 24).
- Medical history of neurological pathology with a deficit as consequence (Rankin < 3 before stroke).
- Serious psychiatric disease.
- Myocardial infarction less than 3 month old.
- Recurring thromboembolic disease or less than 6 month old.
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- Patient with organ transplantation.
- Medical history of infection (HIV,HTLV, HBV, HCV).
- Current immunosuppressive/immunomodulating treatment.
- Medical history of cancer.
- Medical history of chemotherapy.
- Known chronic kidney failure(clearance of creatinin < 90 ml/min/1,73m2).
- Known hepatic failure(diminution of prothrombin level (TP) not corrigiable with vitamin K).
- Obesity hinding the bone-marrow sampling in the iliac crest.
- Pathology implying vital prognosis in the 3 month following stroke.
- Refusal to participate.
- Patient unable to give personally his/her consent.
- Pregnant, parturient and feeding women.
- Woman in age to procreate who could not receive an effective method of contraception during the study.
- Participation to another therapeutic clinical trial or in period of exclusion of a therapeutic clinical study.
- Privation of liberty with a decision of justice or administration, legal protection.
- Non affiliation to social security.
Trial locations and contacts
3 sites in 1 country.
France3 sites
Neuroradiology/MRI, University Hospital of Grenoble
Grenoble, 38000
Stroke Unit, University Hospital of Grenoble
Grenoble, 38000
Tissular and cell therapy unit, UniversityHospitalof Grenoble
Grenoble, 38000
About this study
Official title: Cell Therapy by Intravenous Injection of Mesenchymal Stem Cells After Stroke
The main objective of the study is to evaluate feasibility and tolerance of the intravenous injection of autologous mesenchymal stem cells for patients presenting an ischemic stroke (less than 6 weeks).
Read the detailed description
Stroke is the leading cause of acquired adult disability. Except the hospitalization in stroke units, only thrombolysis has been shown to be efficient to treat acute ischemic stroke in the first three hours after the onset. Increasing brain plasticity after stroke represents an important alternative strategy. Cell therapy provides a functional improvement after cerebral ischemia in rodent models. This "restorative" therapy aims to replace destroyed cerebral tissue with a stem cells graft. Despite these encouraging experiments, we do not know yet the best way of administration of the stem cells, the best dose and the optimal delay of the graft. The pioneer clinical studies failed to reproduce this benefit for patients probably because of the limited number of studied patients. Therefore, more translational studies are needed to improve our knowledge in this promising field. Among different cell sources, mesenchymal (or stromal) stem cells (MSC) derived from bone marrow offer the advantage of arising from a non tumoral and no modified source and are not sources of immunological or ethical problems.
Our research project involves a development of cell therapy in a phase IIa clinical trial of feasibility and safety in patients (randomised, controlled, open, with 3 parallel groups).
- Being tested
- Autologous mesenchymal stem cells
- Keywords
- Cell therapy, Stroke, Neuronal Plasticity, Recovery, Mesenchymal Stem Cells, Transplantation
- Medical subject headings
- Ischemia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous mesenchymal stem cellsGenetic
Intravenous injection of Mesenchymal Stem Cells in a mixing of physiological salt solution/albumin 4% (volume<100ml) less than 6 weeks after stroke
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Control group without intervention nor placebo |
| 2 | Experimental | First dose of stem cells Receives: Genetic: Autologous mesenchymal stem cells |
| 3 | Experimental | Second dose of stem cells Receives: Genetic: Autologous mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
feasibility and tolerance of the intravenous injection of autologous mesenchymal stem cells in patients with carotid ischemic stroke
Measured: 2 weeks, 1, 2, 4, 6 months and 1, 2 years
Secondary outcomes (4)
Clinical and functional effects of the intravenous injection of autologous mesenchymal stem cells in patients with carotid ischemic stroke
Measured: 2 weeks, 1, 2, 4, 6 months and 1, 2 years
Determination of the most effective dose of stem cells
Measured: 2 weeks, 1, 2, 4, 6 months and 1, 2 years
To define the best criteria for a future trial (phase III)
Measured: 2 weeks, 1, 2, 4, 6 months and 1, 2 years
To define the best target population for a future study
Measured: 2 weeks, 1, 2, 4, 6 months and 1, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2009 (estimated)
- Study startAug 2010
- Primary completion20 Oct 2017
- Study completion20 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for IschemiaStudies 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
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Commissariat A L'energie Atomique, Institut National de la Santé Et de la Recherche Médicale, France
- Responsible party
- Principal investigator, AdministrateurCIC, University Hospital, Grenoble
- Investigators
- Olivier Detante, MD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00875654
- Sponsor's protocol ID
- DCIC 06 25
- Acronym
- ISIS
- Status last verified
- Oct 2017
- First submitted
- 2 Apr 2009
- Last updated
- 1 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Jaillard A, Hommel M, Moisan A, Zeffiro TA, Favre-Wiki IM, Barbieux-Guillot M, Vadot W, Marcel S, Lamalle L, Grand S, Detante O; (for the ISIS-HERMES Study Group). Autologous Mesenchymal Stem Cells Improve Motor Recovery in Subacute Ischemic Stroke: a Randomized Clinical Trial. Transl Stroke Res. 2020 Oct;11(5):910-923. doi: 10.1007/s12975-020-00787-z. Epub 2020 May 27.
PubMed 32462427Hannanu FF, Goundous I, Detante O, Naegele B, Jaillard A. Spatiotemporal patterns of sensorimotor fMRI activity influence hand motor recovery in subacute stroke: A longitudinal task-related fMRI study. Cortex. 2020 Aug;129:80-98. doi: 10.1016/j.cortex.2020.03.024. Epub 2020 Apr 17.
PubMed 32438012
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cell Therapy by Intravenous Injection of Mesenchymal Stem Cells After Stroke
- ClinicalTrials.gov ID
- NCT00875654
- Acronym / sponsor ID
- ISIS / DCIC 06 25
- Keywords
- Cell therapy, Stroke, Neuronal Plasticity, Recovery, Mesenchymal Stem Cells, Transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Commissariat A L'energie Atomique, Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Aug 2010
- Primary completion
- 20 Oct 2017 (actual)
- Study completion
- 20 Oct 2017 (actual)
- First posted
- 3 Apr 2009 (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 main objective of the study is to evaluate feasibility and tolerance of the intravenous injection of autologous mesenchymal stem cells for patients presenting an ischemic stroke (less than 6 weeks).
Detailed description
Stroke is the leading cause of acquired adult disability. Except the hospitalization in stroke units, only thrombolysis has been shown to be efficient to treat acute ischemic stroke in the first three hours after the onset. Increasing brain plasticity after stroke represents an important alternative strategy. Cell therapy provides a functional improvement after cerebral ischemia in rodent models. This "restorative" therapy aims to replace destroyed cerebral tissue with a stem cells graft. Despite these encouraging experiments, we do not know yet the best way of administration of the stem cells, the best dose and the optimal delay of the graft. The pioneer clinical studies failed to reproduce this benefit for patients probably because of the limited number of studied patients. Therefore, more translational studies are needed to improve our knowledge in this promising field. Among different cell sources, mesenchymal (or stromal) stem cells (MSC) derived from bone marrow offer the advantage of arising from a non tumoral and no modified source and are not sources of immunological or ethical problems.
Our research project involves a development of cell therapy in a phase IIa clinical trial of feasibility and safety in patients (randomised, controlled, open, with 3 parallel groups).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Control group without intervention nor placebo |
| 2 | Experimental | Genetic: Autologous mesenchymal stem cellsFirst dose of stem cells |
| 3 | Experimental | Genetic: Autologous mesenchymal stem cellsSecond dose of stem cells |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- right or left carotid ischemic stroke in the 14 previous days, confirmed by MRI.
- Persistent neurological deficit (NIHSS >=7).
- Optimal medical treatment(antithrombotics, antihypertensive, statins).
- General state compatible with a program of functional rehabilitation.
Key exclusion criteria (22 listed)
- Severe extensive stroke implying vital prognosis.
- Severe persistent neurological deficit (NIHSS > 24).
- Medical history of neurological pathology with a deficit as consequence (Rankin < 3 before stroke).
- Serious psychiatric disease.
- Myocardial infarction less than 3 month old.
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 mesenchymal stem cellsIntravenous injection of Mesenchymal Stem Cells in a mixing of physiological salt solution/albumin 4% (volume<100ml) less than 6 weeks after stroke | Genetic | 2, 3 |
Primary outcome
feasibility and tolerance of the intravenous injection of autologous mesenchymal stem cells in patients with carotid ischemic stroke
Time frame: 2 weeks, 1, 2, 4, 6 months and 1, 2 years
4 secondary outcomes
Clinical and functional effects of the intravenous injection of autologous mesenchymal stem cells in patients with carotid ischemic stroke
Time frame: 2 weeks, 1, 2, 4, 6 months and 1, 2 years
Determination of the most effective dose of stem cells
Time frame: 2 weeks, 1, 2, 4, 6 months and 1, 2 years
To define the best criteria for a future trial (phase III)
Time frame: 2 weeks, 1, 2, 4, 6 months and 1, 2 years
To define the best target population for a future study
Time frame: 2 weeks, 1, 2, 4, 6 months and 1, 2 years
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 1 Nov 2017.
- Derived from this study: PubMed 32462427Jaillard A, Hommel M, Moisan A, Zeffiro TA, Favre-Wiki IM, Barbieux-Guillot M, Vadot W, Marcel S, Lamalle L, Grand S, Detante O; (for the ISIS-HERMES Study Group). Autologous Mesenchymal Stem Cells Improve Motor Recovery in Subacute Ischemic Stroke: a Randomized Clinical Trial. Transl Stroke Res. 2020 Oct;11(5):910-923. doi: 10.1007/s12975-020-00787-z. Epub 2020 May 27.
- Derived from this study: PubMed 32438012Hannanu FF, Goundous I, Detante O, Naegele B, Jaillard A. Spatiotemporal patterns of sensorimotor fMRI activity influence hand motor recovery in subacute stroke: A longitudinal task-related fMRI study. Cortex. 2020 Aug;129:80-98. doi: 10.1016/j.cortex.2020.03.024. Epub 2020 Apr 17.
- 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.
Olivier Detante, MD principal investigator
University Hospital, Grenoble
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Autologous mesenchymal stem cells in people with Ischemia and Stroke, run by University Hospital, Grenoble at 3 sites in France.
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 22 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 1 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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. 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?
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?
feasibility and tolerance of the intravenous injection of autologous mesenchymal stem cells in patients with carotid ischemic stroke (time frame: 2 weeks, 1, 2, 4, 6 months and 1, 2 years). 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 NCT00875654, which also lists 2 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 1 Nov 2017.