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

Withdrawn

Phase 1/2 Results N/A

Trial Description

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.

Trial Stopped: no enrolled participants

Conditions

Interventions

  • Harvesting and Isolation of Stem Cells Procedure
    Intervention Desc: 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.

Trial Design

  • Allocation: Non-Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Improvement in clinical function from baseline as assessed by the NIH stroke scale at three months 3 months No
Primary Number of participants with adverse events 1 week Yes
Primary Number of participants with adverse events at 2 weeks two weeks Yes
Primary Number of participants with adverse events at 4 weeks 4 weeks Yes
Primary Improvement in clinical function from baseline as assessed by the NIH stroke at 6 months 6 months No
Primary Number of participants with adverse events at 3 weeks 3 weeks Yes
Primary Improvement in clinical function as assessed by Barthel Scale compared to baseline at 6 months 6 months No
Secondary Improvement in clinical function as assessed by Modified Rankin Score compared to baseline at 3 months 3 months No
Secondary Improvement in clinical function as assessed by Barthel Scale compared to baseline at 3 months 3 months No
Secondary Improvement in Magnetic resonance imaging (MRI) scan compared to baseline at three months 3 months No
Secondary Improvement in clinical function as assessed by Modified Rankin Score compared to baseline at 6 months 6 months No
Secondary Improvement in Magnetic resonance imaging (MRI) scan compared to baseline at six months 6 months No

Sponsors