Frailty SyndromeNCT01501461
Study to Assess the Safety and Effects of Autologous Adipose-Derived Stem Cells in Patients With Frailty Syndrome
A study testing Harvesting and implantation of stem cells in people with Frailty Syndrome, 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 health of patients with human frailty syndrome. Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Frailty Syndrome
- What is being tested?
- Harvesting and implantation of stem cells
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteMexico
- Study dates
- 1 May 2011to 30 Jun 2017
- 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 55 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and Females Age >55.
- Frailty syndrome defined by:
- BMD< T-1 (Based on QCT results) Body Mass: males <8% or >17% fat, females<10% or>24% fat (Lean Body Mass=Total Body Mass- %Body Fat)
- Ability to participate in the short physical performance battery
- Up to date on all age and gender appropriate cancer screening per American Cancer Society
Who cannot join
- 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 for HIV, HTLV, HBV, HCV, CMV (IgM > IgG) and/or syphilis. 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
- Active clinical infection being treated by antibiotics within one week of enrollment.
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- 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.
Mexico1 site
Instituto de Medicina Regenerativa
Tijuana, Estado de Baja California, 22010
About this study
Official title: An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Effects of Intra-venous Implantation of Autologous Adipose-Derived Stem Cells in Patients With Frailty Syndrome
The intent of this clinical study is to answer the questions:
- Is the proposed treatment safe
- Is treatment effective in improving the health of patients with human frailty syndrome.
Read the detailed description
This will be an open-label, non-randomized multi-center patient sponsored study of Autologous Adipose-Derived Stem Cells (ASC) implantation after liposuction using an IV 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 intravenously.
- Conditions
- Frailty Syndrome
- Being tested
- Harvesting and implantation of stem cells
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Harvesting and implantation of stem cellsProcedure or surgery
The adipose tissue specimen will be collected from the patient's abdomen or applicable area using tumescent syringe liposuction. The adipose tissue is transferred to the laboratory for separation of the adipose tissue-derived stem cells, which are then transferred for injection intravenously.
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Physical Performance Test (PPT) Results
Measured: 3 months
Number of Adverse Events Reported
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
Improvement in Physical Performance Test (PPT) Results
Measured: 6 months
Improved body composition/bone density compared to baseline
Measured: 3 months
Improved body composition/bone density compared to baseline
Measured: 6 months
Quality of life is improved compared to baseline
Measured: 3 months
Quality of life is improved compared to baseline
Measured: 6 months
Secondary outcomes (2)
Improved exercise capacity compared to baseline
Measured: 3 months
Improved exercise capacity 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 posted29 Dec 2011 (estimated)
- Study start1 May 2011
- Primary completion30 May 2017
- Study completion30 Jun 2017
Why it stopped: Company dissolved
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frailty SyndromeStudies 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
- Clemente Zuniga, MD, Principal investigator, Instituto de Medicina RegenerativaJesus A Perez, MD, Principal investigator, Instituto de Medicina Regenerativa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01501461
- Sponsor's protocol ID
- ADI-ME-FS-001
- Status last verified
- Nov 2017
- First submitted
- 3 Oct 2011
- Last updated
- 19 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2018. 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 Intra-venous Implantation of Autologous Adipose-Derived Stem Cells in Patients With Frailty Syndrome
- ClinicalTrials.gov ID
- NCT01501461
- Acronym / sponsor ID
- ADI-ME-FS-001
- Conditions
- Frailty Syndrome
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Company dissolved
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ageless Regenerative InstituteIndustry (pharma, biotech, devices)
- Collaborators
- Instituto de Medicina Regenerativa
- Study start
- 1 May 2011
- Primary completion
- 30 May 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 29 Dec 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 health of patients with human frailty syndrome.
Detailed description
This will be an open-label, non-randomized multi-center patient sponsored study of Autologous Adipose-Derived Stem Cells (ASC) implantation after liposuction using an IV 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 intravenously.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males and Females Age >55.
- Frailty syndrome defined by:
- BMD< T-1 (Based on QCT results) Body Mass: males <8% or >17% fat, females<10% or>24% fat (Lean Body Mass=Total Body Mass- %Body Fat)
- Ability to participate in the short physical performance battery
- Up to date on all age and gender appropriate cancer screening per American Cancer Society
Key exclusion criteria (9 listed)
- 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 for HIV, HTLV, HBV, HCV, CMV (IgM > IgG) and/or syphilis. 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
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 stem cellsThe adipose tissue specimen will be collected from the patient's abdomen or applicable area using tumescent syringe liposuction. The adipose tissue is transferred to the laboratory for separation of the adipose tissue-derived stem cells, which are then transferred for injection intravenously. | Procedure or surgery | – |
Primary outcome
Improvement in Physical Performance Test (PPT) Results
Time frame: 3 months
Number of Adverse Events Reported
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.
Improvement in Physical Performance Test (PPT) Results
Time frame: 6 months
Improved body composition/bone density compared to baseline
Time frame: 3 months
Improved body composition/bone density compared to baseline
Time frame: 6 months
Quality of life is improved compared to baseline
Time frame: 3 months
Quality of life is improved compared to baseline
Time frame: 6 months
2 secondary outcomes
Improved exercise capacity compared to baseline
Time frame: 3 months
Improved exercise capacity 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 19 Apr 2018.
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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.
Clemente Zuniga, MD principal investigator
Instituto de Medicina Regenerativa
Jesus A Perez, 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 stem cells in people with Frailty Syndrome, 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 5 inclusion and 9 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 19 Apr 2018. 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 Physical Performance Test (PPT) Results (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 19 Apr 2018.