Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells in Patients After Stroke

NCT ID: NCT01453829

Last Updated: 2017-07-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-06-30

Brief Summary

The intent of this clinical study is to answer the questions:

1. Is the proposed treatment safe

2. Is treatment effective in improving the disease pathology of patients after Stroke and clinical outcomes?

Detailed Description

Adipose-Derived Stromal Cells (ASCs) are a novel therapy for patients suffering from stroke. By injecting ASCs either into the internal carotid artery, these regions may become populated with the ASCs, thereby potentially restoring brain function. ASCs are a patient-derived ("autologous") cell transplantation technology that is delivered to the patient into the internal carotid artery and intravenously. The therapy is composed of cells derived from a patients' own adipose tissue that are isolated within approximately 1 hour and immediately delivered back to the patient.

Conditions

Stroke

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Harvesting and Isolation of Stem Cells

This will be an open-label, non-randomized multi-center patient sponsored study of ASC implantation using a catheter delivery system. ASCs will be derived from the patient's adipose-derived tissue. Liposuction using local anesthesia and syringe collection will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells. The cells will be implanted into the Internal Carotid Artery and intravenously.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Males and Females between Age 18 and 80 years.
• Symptoms and signs of clinically definite ischemic stroke or hemorrhagic stroke
• DWI-MRI has reliably shown relevant ischemic lesions
• Extracranial duplex/transcranial Doppler must confirm intra/extracranial arteries permeability
• The stroke is severe (NIH Stroke Scale >= 8 before procedure)
• Up to date on all age and gender appropriate cancer screening per American Cancer Society.

Exclusion Criteria

• Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
• Life expectancy < 6 months due to concomitant illnesses.
• Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.
• Active infectious disease and/or known to have tested positive for HIV, HTLV, HBV, HCV, CMV (IgM > IgG) and/or syphilis will have expert consultation to determine eligibility based on the patient's infectious status
• Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
• Patients on chronic immunosuppressive transplant therapy
• Systolic blood pressure (supine) ≤90 mmHg or greater than 180mmHg
• Resting heart rate > 100 bpm;
• Active clinical infection being treated by antibiotics within one week of enrollment.
• Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.
• History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years.
• Unwilling and/or not able to give written informed consent.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Medicina Regenerativa

INDUSTRY

Sponsor Role: collaborator

Ageless Regenerative Institute

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Victor D Morales, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto de Medicina Regenerativa

Clemente Zuñiga, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto de Medicina Regenerativa

Locations

Hospital Angeles

Tijuana, Estado de Baja California, Mexico

Countries

Mexico

Other Identifiers

ADI-ST-ME-001

Identifier Type: -

Identifier Source: org_study_id