Clinical trial NCT01453777: Safety and Effects of Autologous Adipose-Derived Stromal Cells in Patients With Diffuse Lesions in the Brain
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Brain Lesion (General)
Keywords: diffuse brain lesion
Lead sponsor: Ageless Regenerative Institute
Sponsor class: INDUSTRY
Collaborators: name: Instituto de Medicina Regenerativa
First posted: 2011-10-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 clinical outcomes.

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 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.

Primary outcomes:
measure: Improvement in standardized Gross Motor Function Measure evaluation compared to baseline
timeFrame: 3 months
measure: Number of participants with adverse events
timeFrame: up to 6 months
measure: Improved cognitive function as measured by the mini mental state exam
timeFrame: 3 months
measure: Improvement in standardized Gross Motor Function Measure evaluation compared to baseline
timeFrame: 6 months
measure: Improved cognitive function as measured by the mini mental state exam compared to baseline
timeFrame: 6 months
measure: Reduced depressive symptoms measured by the Beck Depression Inventory compared to baseline
timeFrame: 3 months
measure: Reduced depressive symptoms measured by the Beck Depression Inventory compared to baseline
timeFrame: 6 months
Secondary outcomes:
measure: number of brain lesions by MRI compared to baseline
timeFrame: 3 months
measure: Improved quality of life scores compared to baseline
timeFrame: 3 months
measure: Improved quality of life scores compared to baseline
timeFrame: 6 months
measure: number of brain lesions by MRI compared to baseline
timeFrame: 6 months
Other outcomes:
Locations:
city: Tijuana
country: Mexico
facility: Hospital Angeles
state: Baja California
Study officials:
affiliation: Instituto de Medicina Regenerativa
name: Victor D Morales, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto de Medicina Regenerativa
name: Clemente Zuñiga, md
role: PRINCIPAL_INVESTIGATOR
References: