Status:
WITHDRAWN
Safety and Effects of Autologous Adipose-Derived Stromal Cells in Patients With Diffuse Lesions in the Brain
Lead Sponsor:
Ageless Regenerative Institute
Collaborating Sponsors:
Instituto de Medicina Regenerativa
Conditions:
Brain Lesion (General)
Eligibility:
All Genders
18-80 years
Phase:
NA
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 with diffuse brain lesions and...
Detailed Description
This will be an open-label, non-randomized multi-center patient sponsored study of Adipose-Derived Stromal Cells (ASC) implantation using a catheter delivery system. ASCs will be derived from the pati...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01453777
Start Date
May 1 2011
End Date
June 1 2015
Last Update
July 21 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Angeles
Tijuana, Estado de Baja California, Mexico, 22010