Intra-arterial Bone-marrow Mononuclear Cells Infusion for Acute Ischemic Stroke

Recruiting

Phase 2 Results N/A

Update History

14 Jul '16
Trial name was updated.
New
Intra-arterial Bone-marrow Mononuclear Cells Infusion for Acute Ischemic Stroke
The Summary of Purpose was updated.
New
This trial aims to test that intra-arterial injection of autologous bone marrow mononuclear cells in acute ischemic stroke patients is safe and improves neurological outcomes.
Old
This trial aims to test that intra-arterial infusion of autologous bone marrow mononuclear cells in acute ischemic stroke patients is safe and improves neurological outcomes.
The eligibility criteria were updated.
New
Inclusion Criteria: - Patients with middle cerebral artery (MCA) acute ischemic stroke. - Time of stroke onset is known and treatment can be started between day 1 and 7 of onset. - DWI-MRI has reliably shown acute MCA ischemic lesions - Magnetic resonance angiography (MRA) must confirm ipsilateral MCA permeability - National Institute of Health Stroke Scale score of 6-20 at inclusion - Age 18-80 years - Written informed consent has been obtained Exclusion Criteria: - Hemorrhagic stroke or symptomatic hemorrhagic transformation - Lacunar infarction - Preocclusive stenosis or total occlusion of ipsilateral carotid artery - Worsening of ≥4 points in National Institute of Health Stroke Scale in the 24 hours previous to inclusion, attributable to edema or hemorrhagic transformation or suspicious of malignant edema - Decrease of consciousness with a Glasgow Coma Scale of <8 points - Patients with present or previous malignant disease during the last 5 years, except for basal cell carcinoma - Contraindication for MRI or for bone marrow harvest - Previous diagnosis of neurodegenerative disease - Acute heart failure - Hepatic or renal dysfunction (creatinine >2mg/dL) - Coagulopathy - Severe co-morbidity - Pregnancy, childbearing potential (unless it is certain that pregnancy is not possible) or breast feeding - Modified Rankin Score (mRS) before stroke of ≥2 - Participation in any clinical trial in the last 3 months
Old
Inclusion Criteria: 1. Patients with middle cerebral artery (MCA) acute ischemic stroke. 2. Time of stroke onset is known and treatment can be started between day 1 and 7 of onset. 3. DWI-MRI has reliably shown acute MCA ischemic lesions 4. Magnetic resonance angiography (MRA) must confirm ipsilateral MCA permeability 5. National Institute of Health Stroke Scale score of 6-20 at inclusion 6. Age 18-80 years 7. Written informed consent has been obtained Exclusion Criteria: 1. Hemorrhagic stroke or symptomatic hemorrhagic transformation 2. Lacunar infarction 3. Preocclusive stenosis or total occlusion of ipsilateral carotid artery 4. Worsening of ≥4 points in National Institute of Health Stroke Scale in the 24 hours previous to inclusion, attributable to edema or hemorrhagic transformation or suspicious of malignant edema 5. Patient in coma, with 2 points scored in the first item of NIHSS scale 6. Patients with present or previous malignant disease during the last 5 years, except for basal cell carcinoma 7. Contraindication for MRI or for bone marrow harvest 8. Previous diagnosis of neurodegenerative disease 9. Acute heart failure 10. Hepatic or renal dysfunction (creatinine >2mg/dL) 11. Coagulopathy 12. Severe co-morbidity 13. Pregnancy, childbearing potential (unless it is certain that pregnancy is not possible) or breast feeding 14. Modified Rankin Score (mRS) before stroke of ≥2 15. Participation in any clinical trial in the last 3 months
A location was updated in Cordoba.
New
The overall status was updated to "Recruiting" at Hospital Universitario Reina Sofia.
A location was updated in Málaga.
New
The overall status was updated to "Recruiting" at Hospital Regional Universitario de Málaga.
24 Jun '15
The eligibility criteria were updated.
New
Inclusion Criteria: 1. Patients with middle cerebral artery (MCA) acute ischemic stroke. 2. Time of stroke onset is known and treatment can be started between day 1 and 7 of onset. 3. DWI-MRI has reliably shown acute MCA ischemic lesions 4. Magnetic resonance angiography (MRA) must confirm ipsilateral MCA permeability 5. National Institute of Health Stroke Scale score of 6-20 at inclusion 6. Age 18-80 years 7. Written informed consent has been obtained Exclusion Criteria: 1. Hemorrhagic stroke or symptomatic hemorrhagic transformation 2. Lacunar infarction 3. Preocclusive stenosis or total occlusion of ipsilateral carotid artery 4. Worsening of ≥4 points in National Institute of Health Stroke Scale in the 24 hours previous to inclusion, attributable to edema or hemorrhagic transformation or suspicious of malignant edema 5. Patient in coma, with 2 points scored in the first item of NIHSS scale 6. Patients with present or previous malignant disease during the last 5 years, except for basal cell carcinoma 7. Contraindication for MRI or for bone marrow harvest 8. Previous diagnosis of neurodegenerative disease 9. Acute heart failure 10. Hepatic or renal dysfunction (creatinine >2mg/dL) 11. Coagulopathy 12. Severe co-morbidity 13. Pregnancy, childbearing potential (unless it is certain that pregnancy is not possible) or breast feeding 14. Modified Rankin Score (mRS) before stroke of ≥2 15. Participation in any clinical trial in the last 3 months
Old
Inclusion Criteria: 1. Patients with middle cerebral artery (MCA) acute ischemic stroke. 2. Time of stroke onset is known and treatment can be started between day 1 and 7 of onset. 3. DWI-MRI has reliably shown acute MCA ischemic lesions 4. Magnetic resonance angiography (MRA) must confirm ipsilateral MCA permeability 5. National Institute of Health Stroke Scale score of 6-20 at inclusion 6. Age 18-80 years 7. Written informed consent has been obtained Exclusion Criteria: 1. Hemorrhagic stroke or symptomatic hemorrhagic transformation 2. Lacunar infarction 3. Preocclusive stenosis or total occlusion of ipsilateral carotid artery 4. Worsening of ≥4 points in National Institute of Health Stroke Scale in the 24 hours previous to inclusion, attributable to edema or hemorrhagic transformation or suspicious of malignant edema 5. Decrease of consciousness with a Glasgow Coma Scale of <8 points 6. Patients with present or previous malignant disease during the last 5 years, except for basal cell carcinoma 7. Contraindication for MRI or for bone marrow harvest 8. Previous diagnosis of neurodegenerative disease 9. Acute heart failure 10. Hepatic or renal dysfunction (creatinine >2mg/dL) 11. Coagulopathy 12. Severe co-morbidity 13. Pregnancy, childbearing potential (unless it is certain that pregnancy is not possible) or breast feeding 14. Modified Rankin Score (mRS) before stroke of ≥2 15. Participation in any clinical trial in the last 3 months
16 Jan '15
Trial name was updated.
New
Intra-arterial Autologous Bone-marrow Mononuclear Cells Infusion for Acute Ischemic Stroke
The Summary of Purpose was updated.
New
This trial aims to test that intra-arterial infusion of autologous bone marrow mononuclear cells in acute ischemic stroke patients is safe and improves neurological outcomes.
Old
This is a study in which the patients will be included diagnosed of ischemic stroke sharply in the territory of the cerebral average artery that there fulfill criteria of incorporation and none of those of exclusion and that they have signed the informed assent.
The eligibility criteria were updated.
New
Inclusion Criteria: 1. Patients with middle cerebral artery (MCA) acute ischemic stroke. 2. Time of stroke onset is known and treatment can be started between day 1 and 7 of onset. 3. DWI-MRI has reliably shown acute MCA ischemic lesions 4. Magnetic resonance angiography (MRA) must confirm ipsilateral MCA permeability 5. National Institute of Health Stroke Scale score of 6-20 at inclusion 6. Age 18-80 years 7. Written informed consent has been obtained Exclusion Criteria: 1. Hemorrhagic stroke or symptomatic hemorrhagic transformation 2. Lacunar infarction 3. Preocclusive stenosis or total occlusion of ipsilateral carotid artery 4. Worsening of ≥4 points in National Institute of Health Stroke Scale in the 24 hours previous to inclusion, attributable to edema or hemorrhagic transformation or suspicious of malignant edema 5. Decrease of consciousness with a Glasgow Coma Scale of <8 points 6. Patients with present or previous malignant disease during the last 5 years, except for basal cell carcinoma 7. Contraindication for MRI or for bone marrow harvest 8. Previous diagnosis of neurodegenerative disease 9. Acute heart failure 10. Hepatic or renal dysfunction (creatinine >2mg/dL) 11. Coagulopathy 12. Severe co-morbidity 13. Pregnancy, childbearing potential (unless it is certain that pregnancy is not possible) or breast feeding 14. Modified Rankin Score (mRS) before stroke of ≥2 15. Participation in any clinical trial in the last 3 months
Old
Inclusion Criteria: 1. Patients of both genders with age between 18 and 80 years old. 2. Clinical and radiological diagnosis of ischemic stroke in the MCA (Middle Cerebral Artery) territory after 24 hours of beginning and with not more than 7 days after the appearance of the symptoms. 3. Radiological diagnosis of cerebral stroke and MCA's permeability by magnetic resonance/angio magnetic resonance (RM/aRM). 4. Scale of NIHSS's neurological deficit (National Institutes of Health Stroke Scale) of more than 6 points and up to 20. 5. Loss of strength of at least 2 points in motive items in NIHSS except in the cases of aphasia. 6. Patients who are able to understand the requirements of the study, and willing to provide voluntary written informed consent. Exclusion Criteria: 1. Disability or contraindication for the angiographic examination including the suspicion in arterial dissection. 2. Hemorrhagic Ictus or stroke with hemorrhagic symptomatic transformation. 3. Patients with lacunar stroke. 4. Worsening in NIHSS's scale of 4 points or more in 24 hours before the treatment, attributable to edema and / or cerebral hemorrhage or suspicion in development of malignant stroke of middle cerebral artery. 5. Deficit in the Glasgow comma scale lower than 8 points. 6. Impossibility or contraindication for MR's achievement. 7. Patients with malignant tumors, except basocellular carcinoma. 8. Punctuation in the modified Rankin scale previous to stroke equal or higher than 2. 9. Neurodegenerative diseases. 10. Unbalanced or acute cardiac insufficiency. 11. Coexistence of any type of hematologic disease. 12. Contraindication for the puncture of bone marrow. 13. Clot related diseases. 14. Hepatic insufficiency. 15. Renal moderate insufficiency (creatinine higher of 2 mg / dl). 16. Concomitant serious diseases. 17. Pregnant women, in period of lactation, or in fertile age that they are not using a contraceptive effective method. 18. Patients who are currently enrolled or have been dismissed by a 3 months period.
24 Dec '14
The description was updated.
New
This is a study in which the patients will be included diagnosed of ischemic stroke sharply in the territory of the cerebral average artery that there fulfill criteria of incorporation and none of those of exclusion and that they have signed the informed assent. 76 patients will randomize in proportion 2:1:1 in a group control that will receive only medical conventional treatment and in two groups of intervention that will receive an unique intra-arterial infusion of mononuclear autologous bone marrow stem cells (one group of dose of 2 millions of BMSC for kilogram of weight and another group of dose of 5 millions of BMSC for kilogram of weight). The three groups of patients will be followed for 24 months. The randomization will be stratified depending on the NHSS score. This clinical trial has a voluntary substudy to obtain information on plasma biomarkers.
Old
This is a study in which the patients will be included diagnosed of ischemic stroke sharply in the territory of the cerebral average artery that there fulfill criteria of incorporation and none of those of exclusion and that they have signed the informed assent. 76 patients will randomize in proportion 2:1:1 in a group control that will receive only medical conventional treatment and in two groups of intervention that will receive an unique intra-arterial infusion of mononuclear autologous bone marrow stem cells (dose of 2 millions of BMSC for kilogram of weight and another group of dose of 5 millions of BMSC for kilogram of weight). The three groups of patients will be followed for 24 months. The randomization will be stratified depending on the NHSS score. This clinical trial has a voluntary substudy to obtain information on plasma biomarkers.
The eligibility criteria were updated.
New
Inclusion Criteria: 1. Patients of both genders with age between 18 and 80 years old. 2. Clinical and radiological diagnosis of ischemic stroke in the MCA (Middle Cerebral Artery) territory after 24 hours of beginning and with not more than 7 days after the appearance of the symptoms. 3. Radiological diagnosis of cerebral stroke and MCA's permeability by magnetic resonance/angio magnetic resonance (RM/aRM). 4. Scale of NIHSS's neurological deficit (National Institutes of Health Stroke Scale) of more than 6 points and up to 20. 5. Loss of strength of at least 2 points in motive items in NIHSS except in the cases of aphasia. 6. Patients who are able to understand the requirements of the study, and willing to provide voluntary written informed consent. Exclusion Criteria: 1. Disability or contraindication for the angiographic examination including the suspicion in arterial dissection. 2. Hemorrhagic Ictus or stroke with hemorrhagic symptomatic transformation. 3. Patients with lacunar stroke. 4. Worsening in NIHSS's scale of 4 points or more in 24 hours before the treatment, attributable to edema and / or cerebral hemorrhage or suspicion in development of malignant stroke of middle cerebral artery. 5. Deficit in the Glasgow comma scale lower than 8 points. 6. Impossibility or contraindication for MR's achievement. 7. Patients with malignant tumors, except basocellular carcinoma. 8. Punctuation in the modified Rankin scale previous to stroke equal or higher than 2. 9. Neurodegenerative diseases. 10. Unbalanced or acute cardiac insufficiency. 11. Coexistence of any type of hematologic disease. 12. Contraindication for the puncture of bone marrow. 13. Clot related diseases. 14. Hepatic insufficiency. 15. Renal moderate insufficiency (creatinine higher of 2 mg / dl). 16. Concomitant serious diseases. 17. Pregnant women, in period of lactation, or in fertile age that they are not using a contraceptive effective method. 18. Patients who are currently enrolled or have been dismissed by a 3 months period.
Old
Inclusion Criteria: 1. Patients of both sexes with age between 18 and 80 years old. 2. Clinical and radiological diagnosis of ischemic stroke in the MCA (Middle Cerebral Artery) territory after 24 hours of beginning and with not more than 7 days after the appearance of the symptoms. 3. Radiological diagnosis of cerebral stroke and MCA's permeability by magnetic resonance/angio magnetic resonance (RM/aRM). 4. Scale of NIHSS's neurological deficit (National Institutes of Health Stroke Scale) of more than 6 points and up to 20. 5. Loss of strength of at least 2 points in motive articles in NIHSS except in the cases of aphasia. 6. Patients who are able to understand the requirements of the study, and willing to provide voluntary written informed consent. Exclusion Criteria: 1. Disability or contraindication for the angiographic examination including the suspicion in arterial dissection. 2. Hemorrhagic Ictus or stroke with hemorrhagic symptomatic transformation. 3. Patients with lacunar stroke. 4. Worsening in NIHSS's scale of 4 points or more in 24 hours before the treatment, attributable to edema and / or cerebral hemorrhage or suspicion in development of malignant stroke of middle cerebral artery. 5. Deficit in the Glasgow comma scale lower than 8 points. 6. Impossibility or contraindication for MR's achievement. 7. Patients with malignant tumors, except basocellular carcinoma. 8. Punctuation in the modified Rankin scale previous to stroke equal or higher than 2. 9. Neurodegenerative diseases. 10. Unbalanced or acute cardiac insufficiency. 11. Coexistence of any type of hematologic disease. 12. Contraindication for the puncture of bone marrow. 13. Clot related diseases. 14. Hepatic insufficiency. 15. Renal moderate insufficiency (creatinine higher of 2 mg / dl). 16. Concomitant serious diseases. 17. Pregnant women, in period of lactation, or in fertile age that they are not using a contraceptive effective method. 18. Patients who are currently enrolled or have been dismissed by a 3 months period.