Critical Limb Ischemia (CLI)Phase 1/2NCT02287974

Clinical Trial I/II Opened, Randomized and Controlled for the Study of the Use of Stem Cells Therapy in Insulinized Diabetic Patients Type 2 With Critical Ischemia in Lower Limbs (CLI): Study of the Needs of Insulin

A Phase 1/2 study testing Stem cell infusion in people with Critical Limb Ischemia (CLI), run by Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud at 2 sites in Spain.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

To study the effect of the stem cells therapy autologous mononuclear from the bone marrow, autologous progenitor endothelial CD133 cells from the bone marrow and autologous mesenchymal stem cells from adipose tissue on the inflammatory cytokines, the resistance to insulin and the decrease of the needs of insulin… Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Critical Limb Ischemia (CLI)
What is being tested?: Stem cell infusion
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 2 sitesSpain
Study dates: Sep 2011to Jul 2018
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

Age ≥18 and ≤ 85 years
Diabetic type 2, in treatment with insulin at least 3 previous months.
Vascular disease infrapopliteal atherosclerotic of severe degree (Patients with category Rutherford-Becker ≥ 4), pretty or bilateral. The critical ischemia of the foot is defined as a persistent / persistent pain that needs analgesia and / or not healing present sores> 4 weeks, without evidence of improvement with conventional therapies and / or walking test between 1-6 minutes in two ergometries separated at least for 2 weeks and / or index ankle - arm in rest <0,8.
Impossibility of revascularization surgical or endovascular or I fail in the surgery of revascularization performed at least 30 days before, with persistence or entry in phase of critical ischemia
Life expectancy > 2 years.
Major amputation is not foreseen in any of the members in the next 6 months after the incorporation.

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Normal Biochemical and bone marrow parameters defined for:
Leukocytes ≥ 3000
Neutrophils ≥ 1500
Platelets ≥ 140000
AST/ALT ≤ 2,5 standard range institution
Creatinine ≤2,5 mg/dl and explanation of creatinine ≤ 30 ml/min (MDRD4)
The women in fertile age will have to obtain negative results in a pregnancy test realized in the moment of the incorporation in the study and promise to use a contraceptive method medically approved while the study lasts.
Patients who give his Informed Consent in writing for the participation in the study. 10. Patients who have not taken part in another clinical trial in the last 3 months before the incorporation.

Who cannot join

Precedent of neoplasia or hematologic disease (disease myeloproliferative, syndrome myelodysplasic or leukaemia) in the last 2 years.
Major previous amputation.
Patients with arterial uncontrolled hypertension (defined as arterial tension> 180/110 in more than one occasion).
Cardiac severe insufficiency (NYHA the IVth) or Fraction of Ejection of left ventricle (FAITH) lower than 30 %.
Patients with ventricular malignant arrhythmias or unstable angina.
Diagnosis of venous deep thrombosis in 3 previous months.

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Patients with genotype DD of the ECA or genotype E4 of the apo E.
Concomitant therapy that includes oxygen hyperbaric, vasoactive substances, agents against angiogenesis or inhibiting Cox-II. The agents use is allowed antiplatelets.
Index of corporal mass> 40 Kg/m2.
Patients with the diagnosis of alcoholism in the moment of the incorporation.
Proliferative Retinopathy without possibility of treatment.
Diabetic Nephropathy with haemodialysis
Concomitant disease that reduces the life expectancy to less than 1 years.
Impossibility foreseen to obtain the inhaled one of 100ml of bone marrow.
Infection for HIV, Hepatitis B or Hepatitis C.
Impede in the follow-up.
ACV or heart attack of myocardium in the last 3 months
Anaemia (Haemoglobin <7.9 g/dl)
Patients before treated with cellular therapy.

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

Hopsital U. Virgen Macarena
Seville, Seville, 41007
CABIMER (Andalusian Center for Molecular Biology and Regenerative Medicine)
Seville, 41092

Other trials in Spain

About this study

Official title: Clinical Trial I/II Opened, Randomized and Controlled for the Study of the Use of Stem Cells Therapy in Insulinized Diabetic Patients Type 2 With Critical Ischemia in Lower Limbs: Study of the Needs of Insulin

Read the detailed description

Diabetic patients will include with critical ischemia chronicle of at least a low member limb (CLI) and without possibilities of revascularization. 48 evaluable patients will be included, of which 36 patients will be included in the experimental group (12 for every cellular group) and 12 in the group control by conventional treatment. The population to studying will be constituted by 48 evaluable patients.

Conditions: Critical Limb Ischemia (CLI)
Being tested: Stem cell infusion
Medical subject headings: Chronic Limb-Threatening Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Stem cell infusionDrug
Unique stem cell infusion of the randomized group

Study groups in NCT02287974
Study group	Role	What they receive
Autologous mononuclear stem cell from the bone marrow	Experimental	Autologous mononuclear stem cell from the bone marrow in an unique infusion of 150-250 millions of cells Receives: Drug: Stem cell infusion
Autologous endothelial stem cell from the bone marrow	Experimental	Autologous endothelial progenitor CD133 stem cell from the bone marrow in an unique infusion of 2 - 7 millions of CD133 cells Receives: Drug: Stem cell infusion
Autologous mesenchymal stem cells from the adiposite tissue	Experimental	Autologous mesenchymal stem cells from the adipose tissue in an unique infusion of 0.5 millions of cells Receives: Drug: Stem cell infusion
Current medication for the disease	Active comparator	Current medication for the disease Receives: Drug: Stem cell infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

Serious Adverse Events
To evaluate the possible complications derived from the procedure (in the first 24 hours after the infusion of stem cells and the incident of Serious Adverse Events and not Serious Adverse Events related to the IMPD or to the procedure of administration
Measured: the entire follow-up period, in the first 24 hours after the infusion of stem cells

Secondary outcomes (1)

Efficacy measured by: The changes in the requirements of insulin, Peptide C, Resistance to the insulin, inflammatory Cytokines, pancreatic Reservation, Quantification of the degree of neovascularization (angio/arteriogenesis and vasculogenesis)
Efficacy measured by: The changes in the requirements of insulin, Peptide C, Resistance to the insulin, inflammatory Cytokines, pancreatic Reservation, Quantification of the degree of neovascularization (angio/arteriogenesis and vasculogenesis) after 6 months of the stem cells infusion
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2011Jul 2018

First posted11 Nov 2014 (estimated)
Study startSep 2011
Primary completionJul 2018
Study completionJul 2018

Why it stopped: Patients' numebr randomized not achieved. Investigators team with lack of interest and commitment. The sponsor closed prematurely patients' recruitment.

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: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02287974
Sponsor's protocol ID: CeTMMoTa/ICPDI/2010
Status last verified: Jul 2018
First submitted: 25 Feb 2013
Last updated: 19 Dec 2018
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
FastWire REvascularisation of Extremities, (For LOWer Limbs) - FREEFLOW
Chronic Total Occlusion of Artery of the Extremities
Active, not recruitingObservational study
An All-Comers Observational Study of the MicroStent™ Peripheral Vascular Stent System in Subjects With Peripheral Arterial Disease
Peripheral Arterial Disease, Critical Lower Limb Ischemia
Recruiting
FAZA PET/MRI in CLI Patients Pre and Post Revascularization
Critical Limb Ischemia
Recruiting
PROMISE III: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia
Critical Limb Ischemia, Chronic Limb-Threatening Ischemia
Active, not recruiting
LIFE-BTK PK Sub-study
Critical Limb Ischemia (CLI)

All Critical Limb Ischemia (CLI) trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Trial I/II Opened, Randomized and Controlled for the Study of the Use of Stem Cells Therapy in Insulinized Diabetic Patients Type 2 With Critical Ischemia in Lower Limbs: Study of the Needs of Insulin
ClinicalTrials.gov ID: NCT02287974
Acronym / sponsor ID: CeTMMoTa/ICPDI/2010
Conditions: Critical Limb Ischemia (CLI)
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Patients' numebr randomized not achieved. Investigators team with lack of interest and commitment. The sponsor closed prematurely patients' recruitment.
Enrolment: 20 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: Sep 2011
Primary completion: Jul 2018 (actual)
Study completion: Jul 2018 (actual)
First posted: 11 Nov 2014 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Autologous mononuclear stem cell from the bone marrow	Experimental	Drug: Stem cell infusionAutologous mononuclear stem cell from the bone marrow in an unique infusion of 150-250 millions of cells
Autologous endothelial stem cell from the bone marrow	Experimental	Drug: Stem cell infusionAutologous endothelial progenitor CD133 stem cell from the bone marrow in an unique infusion of 2 - 7 millions of CD133 cells
Autologous mesenchymal stem cells from the adiposite tissue	Experimental	Drug: Stem cell infusionAutologous mesenchymal stem cells from the adipose tissue in an unique infusion of 0.5 millions of cells
Current medication for the disease	Active comparator	Drug: Stem cell infusionCurrent medication for the disease

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

Age ≥18 and ≤ 85 years
Diabetic type 2, in treatment with insulin at least 3 previous months.
Vascular disease infrapopliteal atherosclerotic of severe degree (Patients with category Rutherford-Becker ≥ 4), pretty or bilateral. The critical ischemia of the foot is defined as a persistent / persistent pain that needs analgesia and / or not healing present sores> 4 weeks, without evidence of improvement with conventional therapies and / or walking test between 1-6 minutes in two ergometries separated at least for 2 weeks and / or index ankle - arm in rest <0,8.
Impossibility of revascularization surgical or endovascular or I fail in the surgery of revascularization performed at least 30 days before, with persistence or entry in phase of critical ischemia
Life expectancy > 2 years.

Key exclusion criteria (19 listed)

Precedent of neoplasia or hematologic disease (disease myeloproliferative, syndrome myelodysplasic or leukaemia) in the last 2 years.
Major previous amputation.
Patients with arterial uncontrolled hypertension (defined as arterial tension> 180/110 in more than one occasion).
Cardiac severe insufficiency (NYHA the IVth) or Fraction of Ejection of left ventricle (FAITH) lower than 30 %.
Patients with ventricular malignant arrhythmias or unstable angina.

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
Stem cell infusionUnique stem cell infusion of the randomized group	Drug	Autologous endothelial stem cell from the bone marrow, Autologous mesenchymal stem cells from the adiposite tissue, Autologous mononuclear stem cell from the bone marrow, Current medication for the disease

Primary outcome

Serious Adverse Events
Time frame: the entire follow-up period, in the first 24 hours after the infusion of stem cells
To evaluate the possible complications derived from the procedure (in the first 24 hours after the infusion of stem cells and the incident of Serious Adverse Events and not Serious Adverse Events related to the IMPD or to the procedure of administration

1 secondary outcome

Efficacy measured by: The changes in the requirements of insulin, Peptide C, Resistance to the insulin, inflammatory Cytokines, pancreatic Reservation, Quantification of the degree of neovascularization (angio/arteriogenesis and vasculogenesis)
Time frame: 6 months

Results and safety

The study was stopped early (reason given: Patients' numebr randomized not achieved. Investigators team with lack of interest and commitment. The sponsor closed prematurely patients' recruitment.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.

Related trials for Critical Limb Ischemia (CLI)

Recruiting
FastWire REvascularisation of Extremities, (For LOWer Limbs) - FREEFLOW
Chronic Total Occlusion of Artery of the Extremities
Active, not recruitingObservational study
An All-Comers Observational Study of the MicroStent™ Peripheral Vascular Stent System in Subjects With Peripheral Arterial Disease
Peripheral Arterial Disease, Critical Lower Limb Ischemia
Recruiting
FAZA PET/MRI in CLI Patients Pre and Post Revascularization
Critical Limb Ischemia
Recruiting
PROMISE III: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia
Critical Limb Ischemia, Chronic Limb-Threatening Ischemia
Active, not recruiting
LIFE-BTK PK Sub-study
Critical Limb Ischemia (CLI)

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.

Bernat Soria principal investigator

CABIMER (Centro Andaluz de Biología Molecular y Medicina Regenerativa)

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 14 inclusion and 19 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: stopped early, as of the sponsor's last update on 19 Dec 2018. 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?

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?

Serious Adverse Events (time frame: the entire follow-up period, in the first 24 hours after the infusion of stem cells). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02287974.

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 Dec 2018.