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

Purpose

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?

Condition	Intervention	Phase
Stroke	Procedure: Harvesting and Isolation of Stem Cells	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Further study details as provided by Ageless Regenerative Institute:

Primary Outcome Measures:

Improvement in clinical function from baseline as assessed by the NIH stroke scale at three months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Number of participants with adverse events [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
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 [ Time Frame: two weeks ] [ Designated as safety issue: Yes ]
Number of participants with adverse events at 4 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Improvement in clinical function from baseline as assessed by the NIH stroke at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Number of participants with adverse events at 3 weeks [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
Improvement in clinical function as assessed by Barthel Scale compared to baseline at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Improvement in clinical function as assessed by Modified Rankin Score compared to baseline at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Improvement in clinical function as assessed by Barthel Scale compared to baseline at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Improvement in Magnetic resonance imaging (MRI) scan compared to baseline at three months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Improvement in clinical function as assessed by Modified Rankin Score compared to baseline at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Improvement in clinical function as assessed by Barthel Scale compared to baseline at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Improvement in Magnetic resonance imaging (MRI) scan compared to baseline at six months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	10
Study Start Date:	May 2011
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Intervention Details:

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.

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01453829

Contacts

Contact: Janny Garcia, Biomedical Engineer	(855) 274 -2355	jgarcia@agelessregen.com
Contact: Kristin Comella, Chemical Engineer	(855) 274 -2355	kcomella@agelessregen.com

Locations

Mexico
Hospital Angeles	Recruiting
Tijuana, Baja California, Mexico, 22010
Contact: Jesus Perez, MD jesus.perez.md@gmail.com
Contact: Javier Lopez, MD jjlopezg@ulam.net
Principal Investigator: Victor D Morales, MD
Principal Investigator: Clemente Zuñiga, MD

Sponsors and Collaborators

Ageless Regenerative Institute

Instituto de Medicina Regenerativa, S.A. de C.V.

Investigators

Principal Investigator:	Victor D Morales, MD	Instituto de Medicina Regenerativa
Principal Investigator:	Clemente Zuñiga, MD	Instituto de Medicina Regenerativa

More Information

No publications provided

Responsible Party:	Ageless Regenerative Institute
ClinicalTrials.gov Identifier:	NCT01453829 History of Changes
Other Study ID Numbers:	ADI-ST-ME-001
Study First Received:	October 3, 2011
Last Updated:	October 17, 2011
Health Authority:	Mexico: Federal Commission for Sanitary Risks Protection

Additional relevant MeSH terms:

Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases

Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on May 23, 2013