Nonrevascularizable Critical Ischemia of the Lower LimbsPhase 1/2HULPVASNCT01824069
Treatment CLI Nonrevascularizable Lower Limb With Cell Therapy
A Phase 1/2 study testing Intramuscular injection of a suspension of adult mesenchymal stem cells derived in people with Nonrevascularizable Critical Ischemia of the Lower Limbs, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
Trial summary
It has been demonstrated the feasibility, safety and effectiveness of mesenchymal stem cells derived from lipoaspirate for treating various pathologies fistula. With this project we will address a study population with critical ischemia of lower limbs without possibility of revascularization, either by technical… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Nonrevascularizable Critical Ischemia of the Lower Limbs
- What is being tested?
- Intramuscular injection of a suspension of adult mesenchymal stem cells derived
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2013to Sep 2015
- Phase
- Phase 1/2
- 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
- Informed Consent.
- > 18 years.
- Chronic arterial ischemia grades IV-V of Rutherford that affects at least one limb.
- Arterial occlusion direct flow or distal femoropopliteal level.
- No option for surgical or endovascular revascularization.
- Life expectancy exceeding two years.
- High probability of need for major amputation at 6 months (CLI nonrevascularizable).
- Negative pregnancy test if applicable.
Who cannot join
- Background of hematologic neoplasia or unresolved.
- Hipertensión uncontrolled blood (> 180/110).
- Severe heart Insuficiencia (New York Heart Association [NYHA] IV) or ejection fraction <30%.
- Malignant ventricular, Arritmias.
- Trombosis of deep vein the past three months.
- active infection.
Show all 14Show fewer
- Infarto infarction or stroke the previous three months.
- Medical or psychiatric illness of any kind which, in the opinion of the investigator, may be a reason for exclusion from the study.
- Subjects with congenital or acquired immunodeficiencies. Hepatitis B and / or C or tuberculosis diagnosed at the time of inclusion, treponema.
- Major surgery or severe trauma of the subject in the previous semester.
- Administration of any investigational drug at present to three months prior to enrollment for this trial.
- Pulmonary heart disease, in the opinion of the investigator, be unstable or is sufficiently serious to dismiss the patient from the study.
- Infants or pregnant women.
- Adult women of childbearing potential not using effective contraception during the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase IIa Clinical Trial to Safety of Treatment in Critical Ischemia Nonrevascularizable Lower Limb by Mesenchymal Stem Cells
It has been demonstrated the feasibility, safety and effectiveness of mesenchymal stem cells derived from lipoaspirate for treating various pathologies fistula. With this project we will address a study population with critical ischemia of lower limbs without possibility of revascularization, either by technical criteria (no intervention possible to compensate for the lack of irrigation of a limb) criteria or risk / benefit (intolerable surgical risk for the type of intervention required). It will almost always elderly patients with multiple comorbidities and high surgical risk who have a lower limb ischemia in critical degree, with very high probability of major amputation in the short term or immediate.
Hypothesis: mesenchymal stem cells obtained by lipoaspirate expanded "ex vivo", are capable of promoting angiogenesis de novo to improve critical limb ischemia lower nonrevascularizable a safe manner
Read the detailed description
The primary endpoint of safety and feasibility study will be done when the patient has received treatment at 12 months after implantation. It defines that the process is safe when in the development and monitoring of the trial there has been no adverse events that may be related to the proposed therapy in the trial. All adverse events will be collected during the same time monitoring the clinical evaluation. The main objective will be assessed the cumulative incidence of adverse effects attributed to the study therapy.
Secondary endpoints: As part of the evaluation of the quality of life of patients and clinical evaluation of the treatment will be at 6, 9 and 12 months after implantation a Test SF-12, a magnetic resonance angiography, and tissue oximetry records ankle-brachial index
- Being tested
- Intramuscular injection of a suspension of adult mesenchymal stem cells derived
- Keywords
- Critical Ischemia, Amputation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intramuscular injection of a suspension of adult mesenchymal stem cells derivedOther
Intramuscular injection of a suspension of adult mesenchymal stem cells derived from adipose tissue at doses of 1 million per kilo of weight. Only one dosis by patients
| Study group | Role | What they receive |
|---|---|---|
| Autologous mesenchymal stem cells | Experimental | Intramuscular injection of a suspension of adult mesenchymal stem cells derived from adipose tissue at doses of 1 million per kilo of weight in a dosis Receives: Other: Intramuscular injection of a suspension of adult mesenchymal stem cells derived |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of inject mesenchymal stem cells in MMII
It defines that the process is safe when in the development and monitoring of the trial there has been no adverse events that may be related to the proposed therapy in the trial.
Measured: one year
Secondary outcomes (1)
Quality of life of patients after treatment
We analyze the quality of life of patients by SF-12 test
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2014
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonrevascularizable Critical Ischemia of the Lower LimbsStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario La Paz
- Responsible party
- Sponsor
- Investigators
- Luis Riera del Moral, Doctor, Principal investigator, Instituto de Investigación Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01824069
- Sponsor's protocol ID
- HULPVAS-2011-01
- Other IDs
- 2012-000290-23
- Acronym
- HULPVAS
- Status last verified
- Apr 2013
- First submitted
- 1 Apr 2013
- Last updated
- 15 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIa Clinical Trial to Safety of Treatment in Critical Ischemia Nonrevascularizable Lower Limb by Mesenchymal Stem Cells
- ClinicalTrials.gov ID
- NCT01824069
- Acronym / sponsor ID
- HULPVAS / HULPVAS-2011-01
- Keywords
- Critical Ischemia, Amputation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Collaborators
- Hospital Universitario La Paz
- Study start
- Apr 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 4 Apr 2013 (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.
It has been demonstrated the feasibility, safety and effectiveness of mesenchymal stem cells derived from lipoaspirate for treating various pathologies fistula. With this project we will address a study population with critical ischemia of lower limbs without possibility of revascularization, either by technical criteria (no intervention possible to compensate for the lack of irrigation of a limb) criteria or risk / benefit (intolerable surgical risk for the type of intervention required). It will almost always elderly patients with multiple comorbidities and high surgical risk who have a lower limb ischemia in critical degree, with very high probability of major amputation in the short term or immediate.
Hypothesis: mesenchymal stem cells obtained by lipoaspirate expanded "ex vivo", are capable of promoting angiogenesis de novo to improve critical limb ischemia lower nonrevascularizable a safe manner
Detailed description
The primary endpoint of safety and feasibility study will be done when the patient has received treatment at 12 months after implantation. It defines that the process is safe when in the development and monitoring of the trial there has been no adverse events that may be related to the proposed therapy in the trial. All adverse events will be collected during the same time monitoring the clinical evaluation. The main objective will be assessed the cumulative incidence of adverse effects attributed to the study therapy.
Secondary endpoints: As part of the evaluation of the quality of life of patients and clinical evaluation of the treatment will be at 6, 9 and 12 months after implantation a Test SF-12, a magnetic resonance angiography, and tissue oximetry records ankle-brachial index
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous mesenchymal stem cells | Experimental | Other: Intramuscular injection of a suspension of adult mesenchymal stem cells derivedIntramuscular injection of a suspension of adult mesenchymal stem cells derived from adipose tissue at doses of 1 million per kilo of weight in a dosis |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Informed Consent.
- > 18 years.
- Chronic arterial ischemia grades IV-V of Rutherford that affects at least one limb.
- Arterial occlusion direct flow or distal femoropopliteal level.
- No option for surgical or endovascular revascularization.
Key exclusion criteria (14 listed)
- Background of hematologic neoplasia or unresolved.
- Hipertensión uncontrolled blood (> 180/110).
- Severe heart Insuficiencia (New York Heart Association [NYHA] IV) or ejection fraction <30%.
- Malignant ventricular, Arritmias.
- Trombosis of deep vein the past three months.
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 |
|---|---|---|
| Intramuscular injection of a suspension of adult mesenchymal stem cells derivedIntramuscular injection of a suspension of adult mesenchymal stem cells derived from adipose tissue at doses of 1 million per kilo of weight. Only one dosis by patients | Other | Autologous mesenchymal stem cells |
Primary outcome
Safety of inject mesenchymal stem cells in MMII
Time frame: one year
It defines that the process is safe when in the development and monitoring of the trial there has been no adverse events that may be related to the proposed therapy in the trial.
1 secondary outcome
Quality of life of patients after treatment
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2016.
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.
Luis Riera del Moral, Doctor principal investigator
Instituto de Investigación Hospital Universitario La Paz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Intramuscular injection of a suspension of adult mesenchymal stem cells derived in people with Nonrevascularizable Critical Ischemia of the Lower Limbs, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
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 8 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: finished, as of the sponsor's last update on 15 Jun 2016. 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 Spain. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety of inject mesenchymal stem cells in MMII (time frame: one year). 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 15 Jun 2016.