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

Stroke Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01453829
• Other study ID #: ADI-ST-ME-001
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: October 3, 2011
• Last updated: July 19, 2017
• Start date: October 2014
• Est. completion date: June 2015

Study information

• Verified date: July 2017
• Source: Ageless Regenerative Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Mexico	Hospital Angeles	Tijuana	Baja California

Sponsors (2)

Lead Sponsor	Collaborator
Ageless Regenerative Institute	Instituto de Medicina Regenerativa, S.A. de C.V.

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in clinical function from baseline as assessed by the NIH stroke scale at three months		3 months
Primary	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
Primary	Number of participants with adverse events at 2 weeks		two weeks
Primary	Number of participants with adverse events at 4 weeks		4 weeks
Primary	Improvement in clinical function from baseline as assessed by the NIH stroke at 6 months		6 months
Primary	Number of participants with adverse events at 3 weeks		3 weeks
Primary	Improvement in clinical function as assessed by Barthel Scale compared to baseline at 6 months		6 months
Secondary	Improvement in clinical function as assessed by Modified Rankin Score compared to baseline at 3 months		3 months
Secondary	Improvement in clinical function as assessed by Barthel Scale compared to baseline at 3 months		3 months
Secondary	Improvement in Magnetic resonance imaging (MRI) scan compared to baseline at three months		3 months
Secondary	Improvement in clinical function as assessed by Modified Rankin Score compared to baseline at 6 months		6 months
Secondary	Improvement in clinical function as assessed by Barthel Scale compared to baseline at 6 months		6 months
Secondary	Improvement in Magnetic resonance imaging (MRI) scan compared to baseline at six months		6 months