Ex Vivo Cultured Adult Allogenic MSCs in Ischemic Cerebral Stroke

Stroke Clinical Trial

Official title:

A Randomized, Double Blind, Multicentric, Placebo Controlled, Single Dose, Phase -I/ II Study Assessing The Safety And Efficacy Of Intravenous Ex Vivo Cultured Adult Allogenic Mesenchymal Stem Cells In Patients With Ischemic Cerebral Stroke

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01091701
• Other study ID #: SRM/CS/09-10/001
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: March 22, 2010
• Last updated: May 11, 2016
• Start date: December 2011
• Est. completion date: May 2013

Study information

• Verified date: June 2011
• Source: Stempeutics Research Pvt Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Biological:
• Ex vivo cultured adult allogenic MSCs
Single IV dose of allogenic MSCs

Other:
• Plasmalyte-A
Single IV dose of Plasmalyte-A

Locations

Country	Name	City	State
Malaysia	Hospital Raja Permaisuri Bainun	Jalan Hospital, 30990,	Ipoh, Perak
Malaysia	Hospital Sungai Buloh	Jalan Hospital, 47000	Sungai Buloh, Selangor
Malaysia	Hospital Melaka	Jalan Mufti Haji Khalil, 75400	Melaka
Malaysia	Hospital Kuala Lumpur	Jalan Pahang, 50586	Kuala Lumpur
Malaysia	Hospital Sultanah Bahiyah	Km 6 Jalan Langgar, 5460 Alor Setar, Kedah
Malaysia	Hospital Seberang jaya Jalan Tun Hussein Onn, 13700	Prai	Pulau Pinang

Sponsors (2)

Lead Sponsor	Collaborator
Stempeutics Research Pvt Ltd	Stempeutics Research Malaysia SDN BHD

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The type of AE(s), number of AE(s) and proportion of patients with AE(s).		12 Months	Yes
Primary	Improvement of neurological recovery as assessed by NIH Stroke Scale (NIHSS).		12 Months	No
Secondary	Improvement of the Functional recovery - assessed by Barthel's Index for activities of daily living.		12 Months	No
Secondary	Improvement of Global outcome as assessed by the Modified Rankin Scale		12 Months	No
Secondary	MRI Parameters - Change in infarct size T2 - weighted images and blood flow in infarct area as evaluated by Diffusion Weighted Index		12 Months	No