Ex Vivo Cultured Adult Allogenic MSCs in Ischemic Cerebral Stroke

Stempeutics

Status and phase

Withdrawn

Phase 2

Phase 1

Conditions

Stroke

Treatments

Biological: Ex vivo cultured adult allogenic MSCs

Other: Plasmalyte-A

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT01091701

SRM/CS/09-10/001

Details and patient eligibility

About

This study will evaluate the safety and efficacy of intravenous ex vivo cultured adult allogenic mesenchymal stem cells in patients with ischemic cerebral stroke. Patient will be given single intravenous dose of allogenic mesenchymal stem cells 2 million cells/Kg body weight or placebo within 10 days of stroke. Patients will be followed up till 12 months. Safety will be evaluated by type, number and proportion of patients with adverse events. Efficacy will be evaluated by clinical parameters and MRI.

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age between 20 and 80 years old
MRS equal to or less than 4.
Full functional independence before present stroke.
Patients will be included within the time frame of 10 days after an acute cerebral ischemic episode. This time period refers to the date of dosing.
Neuro-imaging examination showing ischemic cerebral infarct.
CT or MRI brain scanning has reliably excluded both intracranial haemorrhage and structural brain lesions which can mimic stroke (e.g. cerebral tumour)
Stroke symptoms are to be present for at least 30 minutes and have not improved before treatment. Symptoms must be distinguishable from an episode of generalized ischemia (i.e. syncope), seizure, or migraine disorder. Patients should have motor weakness following the acute cerebral ischemic episode.
Able to comply with study procedures for the entire length of the study

Exclusion criteria

Haematological causes of stroke
Evidence of intracranial haemorrhage (ICH) on the CT-scan.
Severe stroke as assessed clinically (e.g. MRS>4).
Subjects who are unlikely to complete the infusion of investigational product and/or are unlikely to undergo active medical management during that period due to a severe clinical condition
Previous intra-cranial hemorrhage, neoplasm, subarachnoid hemorrhage, or arterial venous malformation, intra cranial surgery or radiological evidence of previous cerebral stroke with clinical manifestation.
History of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery)
Size and location of the cerebral infarct cannot be determined.
Comatose / clinically unstable
Serious, pre-existing medical conditions such as bleeding disorders (eg. leukopenia, thrombocytopenia) septicemia, TB, hepatic dysfunction (> 2.5 times the ULN of hepatic function tests) and renal dysfunction (Serum creatinine > 2 mg/dl).
Disease or impairment that precludes adequate neurological exam
Hypo- or hyperglycaemia sufficient to account for the neurological symptoms; the patient should be excluded if their blood glucose is < 3.0 or > 20.0mmol/L.
The patient is female and of childbearing potential (unless it is certain that pregnancy is not possible) or breast feeding.
Patient is likely to be unavailable for follow-up e.g. no fixed home address
Patients with evidence of life threatening infection or life threatening illness (e.g. advanced cancer) or having tested positive for HIV, Hepatitis B, Hepatitis C and VDRL
Patient was already dependent in activities of daily living before the present acute stroke
Patients who have been included in any other clinical trial within the previous month
History of neoplasia or other comorbidity that could impact patient's short-term survival
Previous or concomitant treatment with immune modulators or experimental drugs 60 days prior to study enrolment
Any condition that in the judgment of the investigator would place the patient under undue risk
Sustained systolic BP >220 mmHg, or <80mmHg, or diastolic BP > 140mmHg or <50 mmHg.
Patients contraindicated for MRI examination.