Critical Limb Ischemia (CLI)Phase 1/2NCT01257776
Human Adipose Derived Mesenchymal Stem Cells for Critical Limb Ischemia (CLI) in Diabetic Patients
A Phase 1/2 study testing Autologous adipose derived mesenchymal stem cells in people with Critical Limb Ischemia (CLI) and Diabetes, run by Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud at 2 sites in Spain.
Trial summary
A prospective, multicenter, open, randomized, parallel-group controlled study for two levels of dose. The study population will consist of 30 non-diabetic patients with critical chronic ischemia in at least one of the lower limbs (CLI) and without possibility of revascularization, from whom results can clinically be… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Critical Limb Ischemia (CLI), Diabetes
- What is being tested?
- Autologous adipose derived mesenchymal stem cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 2 sitesSpain
- Study dates
- Dec 2010to Jul 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetes, type 1 or 2
- Critical Limb Ischemia (Rutherford Becker Class II,III or IV)of at least one limb.
- No options for target limb revascularization.
Who cannot join
- Cancer antecedent in the last two years
- Current limb infection or limb gangrene
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
University Hospital Virgen Macarena
Seville, Seville, 41007
CABIMER (Andalusian Center for Molecular Biology and Regenerative Medicine)
Seville, Seville, 41092
About this study
Official title: Using Mesenchymal Stem Cells From Adipose Tissue (CeTMAd) as Cell Regeneration Therapy in Chronic Ischemic Syndrome of Lower Limbs in Diabetic Patients
A prospective, multicenter, open, randomized, parallel-group controlled study for two levels of dose.
The study population will consist of 30 non-diabetic patients with critical chronic ischemia in at least one of the lower limbs (CLI) and without possibility of revascularization, from whom results can clinically be evaluable, of whom, 20 patients will be included in the experimental group (10 for each dose level) and 10 in the control group.
In each of the two dose levels to be used in the study, 15 patients will be included, who will be randomized to the experimental group or the control group according to a distribution 2:1 (2 patients in the experimental group and 1 in control group), thus at each dose level, we will have 10 patients in the experimental group (treated with mesenchymal cells of adipose tissue) and 5 patients in the control group (conventional treatment)
- Conditions
- Critical Limb Ischemia (CLI), Diabetes
- Being tested
- Autologous adipose derived mesenchymal stem cells
- Keywords
- Critical Limb Ischemia (CLI), Diabetes, Mesenchymal Stem Cells, Regenerative Therapy
- Medical subject headings
- Chronic Limb-Threatening Ischemia, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous adipose derived mesenchymal stem cellsDrug
Intra-arterial administration through a selective cannulation of target common femoral artery
| Study group | Role | What they receive |
|---|---|---|
| Mesenchymal stem cells 0,5 million * weight (kg) | Active comparator | Group of low dose of Mesenchymal stem cells. Receives: Drug: Autologous adipose derived mesenchymal stem cells |
| Mesenchymal stem cells 1 million * weight (kg) | Active comparator | Group of mid dose of mesenchymal stem cells Receives: Drug: Autologous adipose derived mesenchymal stem cells |
| Controlled group | No intervention | Controlled group with no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angiographic assessment of neovasculogenesis (angiogenesis plus arteriogenesis)
Target limb vascularization would be quantified by a dedicated software, MetaMorph® v.6.3, by using Angiogenesis Tube Formation application module. Neovasculogenesis would be the difference between vascularization at baseline and 6 months follow-up.
Measured: 6 months
Major adverse event (death, target limb amputation)
Measured: 1 month, 6 months, 12 months
Secondary outcomes (2)
Ankle Brachial Index
Measured: 1 month, 6 months, 12 months
University of Texas Classification at target limb
Measured: 1 month, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionFeb 2013
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Limb Ischemia (CLI)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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
- Sponsor type
- University, hospital or other
- Collaborators
- Iniciativa Andaluza en Terapias Avanzadas
- Responsible party
- Sponsor
- Investigators
- Rafael J Ruiz-Salmeron, MD, PhD, Principal investigator, University Hospital Virgen Macarena. Seville.SpainAntonio De la Cuesta, MD, Principal investigator, University Hospital Virgen Macarena. Seville.Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01257776
- Sponsor's protocol ID
- CeTMAd/ICPD/2008
- Status last verified
- Nov 2014
- First submitted
- 9 Dec 2010
- Last updated
- 5 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Mesenchymal Stem Cells From Adipose Tissue (CeTMAd) as Cell Regeneration Therapy in Chronic Ischemic Syndrome of Lower Limbs in Diabetic Patients
- ClinicalTrials.gov ID
- NCT01257776
- Acronym / sponsor ID
- CeTMAd/ICPD/2008
- Conditions
- Critical Limb Ischemia (CLI), Diabetes
- Keywords
- Critical Limb Ischemia (CLI), Diabetes, Mesenchymal Stem Cells, Regenerative Therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y SaludUniversity, hospital or other
- Collaborators
- Iniciativa Andaluza en Terapias Avanzadas
- Study start
- Dec 2010
- Primary completion
- Feb 2013 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 10 Dec 2010 (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.
A prospective, multicenter, open, randomized, parallel-group controlled study for two levels of dose.
The study population will consist of 30 non-diabetic patients with critical chronic ischemia in at least one of the lower limbs (CLI) and without possibility of revascularization, from whom results can clinically be evaluable, of whom, 20 patients will be included in the experimental group (10 for each dose level) and 10 in the control group.
In each of the two dose levels to be used in the study, 15 patients will be included, who will be randomized to the experimental group or the control group according to a distribution 2:1 (2 patients in the experimental group and 1 in control group), thus at each dose level, we will have 10 patients in the experimental group (treated with mesenchymal cells of adipose tissue) and 5 patients in the control group (conventional treatment)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mesenchymal stem cells 0,5 million * weight (kg) | Active comparator | Drug: Autologous adipose derived mesenchymal stem cellsGroup of low dose of Mesenchymal stem cells. |
| Mesenchymal stem cells 1 million * weight (kg) | Active comparator | Drug: Autologous adipose derived mesenchymal stem cellsGroup of mid dose of mesenchymal stem cells |
| Controlled group | No intervention | –Controlled group with no intervention |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diabetes, type 1 or 2
- Critical Limb Ischemia (Rutherford Becker Class II,III or IV)of at least one limb.
- No options for target limb revascularization.
Key exclusion criteria (2 listed)
- Cancer antecedent in the last two years
- Current limb infection or limb gangrene
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 |
|---|---|---|
| Autologous adipose derived mesenchymal stem cellsIntra-arterial administration through a selective cannulation of target common femoral artery | Drug | Mesenchymal stem cells 0,5 million * weight (kg), Mesenchymal stem cells 1 million * weight (kg) |
Primary outcome
Angiographic assessment of neovasculogenesis (angiogenesis plus arteriogenesis)
Time frame: 6 months
Target limb vascularization would be quantified by a dedicated software, MetaMorph® v.6.3, by using Angiogenesis Tube Formation application module. Neovasculogenesis would be the difference between vascularization at baseline and 6 months follow-up.
Major adverse event (death, target limb amputation)
Time frame: 1 month, 6 months, 12 months
2 secondary outcomes
Ankle Brachial Index
Time frame: 1 month, 6 months, 12 months
University of Texas Classification at target limb
Time frame: 1 month, 6 months, 12 months
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 5 Aug 2015.
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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.
Rafael J Ruiz-Salmeron, MD, PhD principal investigator
University Hospital Virgen Macarena. Seville.Spain
Antonio De la Cuesta, MD principal investigator
University Hospital Virgen Macarena. Seville.Spain
2 sites 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 Autologous adipose derived mesenchymal stem cells in people with Critical Limb Ischemia (CLI) and Diabetes, run by Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud at 2 sites 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 3 inclusion and 2 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 5 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Angiographic assessment of neovasculogenesis (angiogenesis plus arteriogenesis) (time frame: 6 months). The study lists 2 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 5 Aug 2015.