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

NCT01453829 | Withdrawn Phase 1

• 1 other identifier: ADI-ST-ME-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The intent of this clinical study is to answer the questions:

1. 1.Is the proposed treatment safe
2. 2.Is treatment effective in improving the disease pathology of patients after Stroke and clinical outcomes?

Conditions

Stroke

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (6)

• 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 clinical function as assessed by Barthel Scale compared to baseline at 6 months

  6 months

Interventions

Harvesting and Isolation of Stem Cells PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ageless Regenerative Institute: lead
• Instituto de Medicina Regenerativa: collaborator

Study Sites (1)

Hospital Angeles

Tijuana, Estado de Baja California, 22010, Mexico

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Victor D Morales, MD

  Instituto de Medicina Regenerativa

  PRINCIPAL INVESTIGATOR

• Clemente Zuñiga, MD

  Instituto de Medicina Regenerativa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2011
• First Posted: October 18, 2011
• Study Start: October 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: June 1, 2015
• Last Updated: July 21, 2017

Record last verified: 2017-07

Locations

ME (1)