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

This study is currently recruiting participants.

Verified November 2011 by Ageless Regenerative Institute

Sponsor:

Collaborator:

Instituto de Medicina Regenerativa, S.A. de C.V.

Information provided by (Responsible Party):

Ageless Regenerative Institute

ClinicalTrials.gov Identifier:

NCT01453777

First received: October 3, 2011

Last updated: November 1, 2011

Last verified: November 2011

History of Changes

Purpose

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

Is the proposed treatment safe
Is treatment effective in improving the disease pathology of patients with diffuse brain lesions and clinical outcomes.

Condition	Intervention	Phase
Brain Lesion (General)	Procedure: harvesting and implantation of adipose derived stem cells	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered Via Catheter Into the Internal Carotid Artery and Intravenously in Patients With Diffuse Lesions in the Brain

Resource links provided by NLM:

MedlinePlus related topics: Depression

U.S. FDA Resources

Further study details as provided by Ageless Regenerative Institute:

Primary Outcome Measures:

Improvement in standardized Gross Motor Function Measure evaluation compared to baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Number of participants with adverse events [ Time Frame: up to 6 months ] [ Designated as safety issue: Yes ]
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.
Improved cognitive function as measured by the mini mental state exam [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Improvement in standardized Gross Motor Function Measure evaluation compared to baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Improved cognitive function as measured by the mini mental state exam compared to baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Reduced depressive symptoms measured by the Beck Depression Inventory compared to baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Reduced depressive symptoms measured by the Beck Depression Inventory compared to baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

number of brain lesions by MRI compared to baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Improved quality of life scores compared to baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Improved quality of life scores compared to baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]
number of brain lesions by MRI compared to baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	10
Study Start Date:	May 2011
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Intervention Details:

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.

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 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 delivered via catheter into the internal carotid artery and intravenously.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01453777

Contacts

Contact: Janny Garcia, Biomedical Engineer	(855) 274 -2355	jgarcia@agelessregen.com
Contact: Kristin Comella, Chemical Engineer	(855) 274 -2355	kcomella@agelessregen.com

Locations

Mexico
Hospital Angeles	Recruiting
Tijuana, Baja California, Mexico, 22010
Contact: Jesus A Perez, MD jesus.perez.md@gmail.com
Contact: Javier Lopez, MD jjlopezg@ulam.net
Principal Investigator: Victor D Morales, MD
Principal Investigator: Clemente Zuñiga, MD

Sponsors and Collaborators

Ageless Regenerative Institute

Instituto de Medicina Regenerativa, S.A. de C.V.

Investigators

Principal Investigator:	Victor D Morales, MD	Instituto de Medicina Regenerativa
Principal Investigator:	Clemente Zuñiga, md	Instituto de Medicina Regenerativa

More Information

No publications provided

Responsible Party:	Ageless Regenerative Institute
ClinicalTrials.gov Identifier:	NCT01453777 History of Changes
Other Study ID Numbers:	ADI-ME-DL-001
Study First Received:	October 3, 2011
Last Updated:	November 1, 2011
Health Authority:	Mexico: Federal Commission for Sanitary Risks Protection

Keywords provided by Ageless Regenerative Institute:

diffuse brain lesion

Additional relevant MeSH terms:

Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 16, 2013

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