Clinical trial NCT01453829: 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
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Stroke
Lead sponsor: Ageless Regenerative Institute
Sponsor class: INDUSTRY
Collaborators: name: Instituto de Medicina Regenerativa
First posted: 2011-10-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Improvement in clinical function from baseline as assessed by the NIH stroke scale at three months
timeFrame: 3 months
measure: Number of participants with adverse events
timeFrame: 1 week
measure: Number of participants with adverse events at 2 weeks
timeFrame: two weeks
measure: Number of participants with adverse events at 4 weeks
timeFrame: 4 weeks
measure: Improvement in clinical function from baseline as assessed by the NIH stroke at 6 months
timeFrame: 6 months
measure: Number of participants with adverse events at 3 weeks
timeFrame: 3 weeks
measure: Improvement in clinical function as assessed by Barthel Scale compared to baseline at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Improvement in clinical function as assessed by Modified Rankin Score compared to baseline at 3 months
timeFrame: 3 months
measure: Improvement in clinical function as assessed by Barthel Scale compared to baseline at 3 months
timeFrame: 3 months
measure: Improvement in Magnetic resonance imaging (MRI) scan compared to baseline at three months
timeFrame: 3 months
measure: Improvement in clinical function as assessed by Modified Rankin Score compared to baseline at 6 months
timeFrame: 6 months
measure: Improvement in clinical function as assessed by Barthel Scale compared to baseline at 6 months
timeFrame: 6 months
measure: Improvement in Magnetic resonance imaging (MRI) scan compared to baseline at six months
timeFrame: 6 months
Other outcomes:
Locations:
city: Tijuana
country: Mexico
facility: Hospital Angeles
state: Baja California
Study officials:
affiliation: Instituto de Medicina Regenerativa
name: Victor D Morales, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto de Medicina Regenerativa
name: Clemente Zuñiga, MD
role: PRINCIPAL_INVESTIGATOR
References: