Ex Vivo Cultured Adult Allogenic MSCs in Ischemic Cerebral Stroke

NCT01091701 | Withdrawn Phase 1 DMC

• 1 other identifier: SRM/CS/09-10/001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Stroke

Keywords

Ischemic Cerebral Stroke

Outcome Measures

Primary Outcomes (2)

• The type of AE(s), number of AE(s) and proportion of patients with AE(s).

  12 Months

• Improvement of neurological recovery as assessed by NIH Stroke Scale (NIHSS).

  12 Months

Secondary Outcomes (3)

• Improvement of the Functional recovery - assessed by Barthel's Index for activities of daily living.

  12 Months

• Improvement of Global outcome as assessed by the Modified Rankin Scale

  12 Months

• MRI Parameters - Change in infarct size T2 - weighted images and blood flow in infarct area as evaluated by Diffusion Weighted Index

  12 Months

Study Arms (2)

Ex vivo cultured adult allogenic MSCs

EXPERIMENTAL

Biological: Ex vivo cultured adult allogenic MSCs

Plasmalyte-A

PLACEBO COMPARATOR

Other: Plasmalyte-A

Interventions

Ex vivo cultured adult allogenic MSCs BIOLOGICAL

Single IV dose of allogenic MSCs

Ex vivo cultured adult allogenic MSCs

Plasmalyte-A OTHER

Single IV dose of Plasmalyte-A

Plasmalyte-A

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stempeutics Research Pvt Ltd: lead
• Stempeutics Research Malaysia SDN BHD: collaborator

Study Sites (6)

Hospital Raja Permaisuri Bainun

Jalan Hospital, 30990,, Ipoh, Perak, Malaysia

Location

Hospital Kuala Lumpur

Jalan Pahang, 50586, Kuala Lumpur, Malaysia

Location

Hospital Melaka

Jalan Mufti Haji Khalil, 75400, Melaka, Malaysia

Location

Hospital Seberang jaya Jalan Tun Hussein Onn, 13700

Perai, Pulau Pinang, Malaysia

Location

Hospital Sungai Buloh

Jalan Hospital, 47000, Sungai Buloh, Selangor, Malaysia

Location

Hospital Sultanah Bahiyah

Km 6 Jalan Langgar, 5460 Alor Setar, Kedah, Malaysia

Location

MeSH Terms

Conditions

Stroke

Interventions

Plasmalyte A

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Dr Abdul Syukur Abdullah, MD

  Hospital Sultanah Bahiyah Consultant Physician, Medical Department, Km 6 Jalan Langgar, 5460 Alor Setar, Kedah

  PRINCIPAL INVESTIGATOR

• Dr Irene Looi, MD

  Hospital Seberang jaya Jalan Tun Hussein Onn 13700 Prai, Pulau Pinang

  PRINCIPAL INVESTIGATOR

• Dr Uduman Ali Mohamed Yousuf, MD

  Hospital Melaka Consultant Neurologist, Neurology Clinic, Medical Department, Jalan Mufti Haji Khalil, 75400 Melaka

  PRINCIPAL INVESTIGATOR

• Dr Dato K Chandran, MD

  Hospital Raja Permaisuri Bainun Consultant Physician, Jalan Hospital, 30990,Ipoh, Perak

  PRINCIPAL INVESTIGATOR

• Dr Chuah Siew Kee, MD

  Hospital Sungai Buloh Consultant Physician, Department of Medicine, Jalan Hospital, 47000 Sungai Buloh, Selangor

  PRINCIPAL INVESTIGATOR

• Dr Yau Weng Keong, MD

  Hospital Kuala Lumpur Consultant Physian and Geriatrician, Jalan Pahang, 50586 Kuala Lumpur

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 22, 2010
• First Posted: March 24, 2010
• Study Start: December 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: May 12, 2016

Record last verified: 2011-06

Locations

MY (6)