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

An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered Into the Internal Carotid Artery and Intravenously in Patients After Stroke

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?

Study Overview

• Status: Withdrawn
• Conditions: Stroke
• Intervention / Treatment: Procedure: Harvesting and Isolation of Stem Cells

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.

• Study Type: Interventional
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Mexico
  • Baja California
    • Tijuana, Baja California, Mexico, 22010
      • Hospital Angeles

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in clinical function from baseline as assessed by the NIH stroke scale at three months		3 months
Number of participants with adverse events	The safety of adipose-derived stem cell injection will be evaluated by assessment of the frequency and nature of adverse events occurring during the study injection and up to the 6-month period following treatment.	1 week
Number of participants with adverse events at 2 weeks		two weeks
Number of participants with adverse events at 4 weeks		4 weeks
Improvement in clinical function from baseline as assessed by the NIH stroke at 6 months		6 months
Number of participants with adverse events at 3 weeks		3 weeks
Improvement in clinical function as assessed by Barthel Scale compared to baseline at 6 months		6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Improvement in clinical function as assessed by Barthel Scale compared to baseline at 6 months	6 months
Improvement in clinical function as assessed by Modified Rankin Score compared to baseline at 3 months	3 months
Improvement in clinical function as assessed by Barthel Scale compared to baseline at 3 months	3 months
Improvement in Magnetic resonance imaging (MRI) scan compared to baseline at three months	3 months
Improvement in clinical function as assessed by Modified Rankin Score compared to baseline at 6 months	6 months
Improvement in Magnetic resonance imaging (MRI) scan compared to baseline at six months	6 months

Collaborators and Investigators

• Sponsor: Ageless Regenerative Institute
• Collaborators: Instituto de Medicina Regenerativa

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (ANTICIPATED): December 1, 2014
• Study Completion (ANTICIPATED): June 1, 2015

Study Registration Dates

• First Submitted: October 3, 2011
• First Submitted That Met QC Criteria: October 17, 2011
• First Posted (ESTIMATE): October 18, 2011

Study Record Updates

• Last Update Posted (ACTUAL): July 21, 2017
• Last Update Submitted That Met QC Criteria: July 19, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: ADI-ST-ME-001