Brain Lesion (General)NCT01453777
Safety and Effects of Autologous Adipose-Derived Stromal Cells in Patients With Diffuse Lesions in the Brain
A study testing harvesting and implantation of adipose derived stem cells in people with Brain Lesion (General), run by Ageless Regenerative Institute at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Brain Lesion (General)
- What is being tested?
- harvesting and implantation of adipose derived stem cells
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteMexico
- Study dates
- May 2011to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Brain Lesion (General)
- Being tested
- harvesting and implantation of adipose derived stem cells
- Keywords
- diffuse brain lesion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
harvesting and implantation of adipose derived stem cellsProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in standardized Gross Motor Function Measure evaluation compared to baseline
Measured: 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.
Measured: up to 6 months
Improved cognitive function as measured by the mini mental state exam
Measured: 3 months
Improvement in standardized Gross Motor Function Measure evaluation compared to baseline
Measured: 6 months
Improved cognitive function as measured by the mini mental state exam compared to baseline
Measured: 6 months
Reduced depressive symptoms measured by the Beck Depression Inventory compared to baseline
Measured: 3 months
Reduced depressive symptoms measured by the Beck Depression Inventory compared to baseline
Measured: 6 months
Secondary outcomes (4)
number of brain lesions by MRI compared to baseline
Measured: 3 months
Improved quality of life scores compared to baseline
Measured: 3 months
Improved quality of life scores compared to baseline
Measured: 6 months
number of brain lesions by MRI compared to baseline
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2011 (estimated)
- Study startMay 2011
- Primary completionDec 2014 (estimated)
- Study completionJun 2015 (estimated)
Why it stopped: No participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Lesion (General)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ageless Regenerative Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Instituto de Medicina Regenerativa
- Responsible party
- Sponsor
- Investigators
- Victor D Morales, MD, Principal investigator, Instituto de Medicina RegenerativaClemente Zuñiga, md, Principal investigator, Instituto de Medicina Regenerativa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01453777
- Sponsor's protocol ID
- ADI-ME-DL-001
- Status last verified
- Mar 2017
- First submitted
- 3 Oct 2011
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01453777
- Acronym / sponsor ID
- ADI-ME-DL-001
- Conditions
- Brain Lesion (General)
- Keywords
- diffuse brain lesion
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ageless Regenerative InstituteIndustry (pharma, biotech, devices)
- Collaborators
- Instituto de Medicina Regenerativa
- Study start
- May 2011
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 18 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| harvesting and implantation of adipose derived stem cellsAdipose-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. | Procedure or surgery | – |
Primary outcome
Improvement in standardized Gross Motor Function Measure evaluation compared to baseline
Time frame: 3 months
Number of participants with adverse events
Time frame: up to 6 months
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
Improvement in standardized Gross Motor Function Measure evaluation compared to baseline
Time frame: 6 months
Improved cognitive function as measured by the mini mental state exam compared to baseline
Time frame: 6 months
Reduced depressive symptoms measured by the Beck Depression Inventory compared to baseline
Time frame: 3 months
Reduced depressive symptoms measured by the Beck Depression Inventory compared to baseline
Time frame: 6 months
4 secondary outcomes
number of brain lesions by MRI compared to baseline
Time frame: 3 months
Improved quality of life scores compared to baseline
Time frame: 3 months
Improved quality of life scores compared to baseline
Time frame: 6 months
number of brain lesions by MRI compared to baseline
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victor D Morales, MD principal investigator
Instituto de Medicina Regenerativa
Clemente Zuñiga, md principal investigator
Instituto de Medicina Regenerativa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing harvesting and implantation of adipose derived stem cells in people with Brain Lesion (General), run by Ageless Regenerative Institute at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in standardized Gross Motor Function Measure evaluation compared to baseline (time frame: 3 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2017.