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

Primary Purpose

Stroke

Status
Withdrawn
Phase
Phase 1
Locations
Mexico
Study Type
Interventional
Intervention
Harvesting and Isolation of Stem Cells
Sponsored by
Ageless Regenerative Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Angeles

Outcomes

Primary Outcome Measures

Improvement in clinical function from baseline as assessed by the NIH stroke scale at three 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.
Number of participants with adverse events at 2 weeks
Number of participants with adverse events at 4 weeks
Improvement in clinical function from baseline as assessed by the NIH stroke at 6 months
Number of participants with adverse events at 3 weeks
Improvement in clinical function as assessed by Barthel Scale compared to baseline at 6 months

Secondary Outcome Measures

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

Full Information

First Posted
October 3, 2011
Last Updated
July 19, 2017
Sponsor
Ageless Regenerative Institute
Collaborators
Instituto de Medicina Regenerativa
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1. Study Identification

Unique Protocol Identification Number
NCT01453829
Brief Title
Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells in Patients After Stroke
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Withdrawn
Why Stopped
no enrolled participants
Study Start Date
October 2014 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
June 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ageless Regenerative Institute
Collaborators
Instituto de Medicina Regenerativa

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The intent of this clinical study is to answer the questions: Is the proposed treatment safe 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Harvesting and Isolation of Stem Cells
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improvement in clinical function from baseline as assessed by the NIH stroke scale at three months
Time Frame
3 months
Title
Number of participants with adverse events
Description
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.
Time Frame
1 week
Title
Number of participants with adverse events at 2 weeks
Time Frame
two weeks
Title
Number of participants with adverse events at 4 weeks
Time Frame
4 weeks
Title
Improvement in clinical function from baseline as assessed by the NIH stroke at 6 months
Time Frame
6 months
Title
Number of participants with adverse events at 3 weeks
Time Frame
3 weeks
Title
Improvement in clinical function as assessed by Barthel Scale compared to baseline at 6 months
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Improvement in clinical function as assessed by Modified Rankin Score compared to baseline at 3 months
Time Frame
3 months
Title
Improvement in clinical function as assessed by Barthel Scale compared to baseline at 3 months
Time Frame
3 months
Title
Improvement in Magnetic resonance imaging (MRI) scan compared to baseline at three months
Time Frame
3 months
Title
Improvement in clinical function as assessed by Modified Rankin Score compared to baseline at 6 months
Time Frame
6 months
Title
Improvement in clinical function as assessed by Barthel Scale compared to baseline at 6 months
Time Frame
6 months
Title
Improvement in Magnetic resonance imaging (MRI) scan compared to baseline at six months
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victor D Morales, MD
Organizational Affiliation
Instituto de Medicina Regenerativa
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Clemente Zuñiga, MD
Organizational Affiliation
Instituto de Medicina Regenerativa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Angeles
City
Tijuana
State/Province
Baja California
ZIP/Postal Code
22010
Country
Mexico

12. IPD Sharing Statement

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

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