Safety and Effects of Autologous Adipose-Derived Stromal Cells in Patients With Diffuse Lesions in the Brain

NCT01453777 | Withdrawn

• 1 other identifier: ADI-ME-DL-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 with diffuse brain lesions and clinical outcomes.

Conditions

Brain Lesion (General)

Keywords

diffuse brain lesion

Outcome Measures

Primary Outcomes (7)

• Improvement in standardized Gross Motor Function Measure evaluation compared to baseline

  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.

  up to 6 months

• Improved cognitive function as measured by the mini mental state exam

  3 months

• Improvement in standardized Gross Motor Function Measure evaluation compared to baseline

  6 months

• Improved cognitive function as measured by the mini mental state exam compared to baseline

  6 months

• Reduced depressive symptoms measured by the Beck Depression Inventory compared to baseline

  3 months

• Reduced depressive symptoms measured by the Beck Depression Inventory compared to baseline

  6 months

Secondary Outcomes (4)

• number of brain lesions by MRI compared to baseline

  3 months

• Improved quality of life scores compared to baseline

  3 months

• Improved quality of life scores compared to baseline

  6 months

• number of brain lesions by MRI compared to baseline

  6 months

Interventions

harvesting and implantation of adipose derived stem cells PROCEDURE

Adipose-Derived Stem cells will be derived from the patient's fat 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 delivered via catheter 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.
• Patient with current diagnosis of Diffuse Brain Lesions with cognitive and/or functional impairment
• MRI not showing gross atrophy or any other pathology of brain.
• Up to date on all age and gender appropriate cancer screening per American Cancer Society

You may not qualify if:

• Contraindication for MRI
• General medical contraindications for minor surgery or angiography
• 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. Patients known to have tested positive will have an expert consulted as to patient 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;
• Resting heart rate \> 100 bpm;
• Active clinical infection 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

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: not applicable
• 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: May 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: June 1, 2015
• Last Updated: July 21, 2017

Record last verified: 2017-03

Locations

ME (1)