Peripheral Arterial DiseaseNCT03635970
Cell Therapy for Peripheral Arterial Disease and Diabetes
A study testing celular therapy in people with Peripheral Arterial Disease and Diabetes Mellitus, run by Hospital Regional de Alta Especialidad del Bajio at 1 site in Mexico.
Trial summary
This is a randomized controlled trial with blinding (for the observer who evaluates treatment goals). With two groups to study. A group of patients with conventional therapy for the treatment of PAD (Platelet antiaggregant, statin, cilostazol in case of claudication) and the other group of patients with conventional… Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Peripheral Arterial Disease, Diabetes Mellitus
- What is being tested?
- celular therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteMexico
- Study dates
- 18 May 2018to 27 Jul 2020
- 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 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with affiliation to the Mexican Institute of Social Security.
- Patients older than 35 years.
- Patients with Type 2 Diabetes Mellitus over 10 years of detection.
- Patients with Peripheral Arterial Disease with ABI between 0.6 and 0.9.
- Signature of informed consent.
Who cannot join
- Patients with a history of uncontrolled oncological disease in the last 5 years.
- Presence of Chronic Renal Insufficiency with a calculated creatinine clearance using a Cockcroft formula less than 15ml / min.
- Ulcer that defines diabetic foot or tissue necrosis that requires partial or total amputation of a limb.
- Serious active infectious process anywhere in the body.
- Have restrictions with the use of filgrastim such as treatment with lithium, chemotherapy or radiotherapy, as well as a history of autoimmune thrombocytopenia, vasculitis, previous cardiovascular disease, Sweet's syndrome or Steven-Johnson syndrome.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Microvascular Effect After the Application of Cell Therapy With a Hematopoietic Stem Cell Concentrate in Patients With Peripheral Arterial Disease With Non-critical Ischemia and Diabetes
This is a randomized controlled trial with blinding (for the observer who evaluates treatment goals).
With two groups to study. A group of patients with conventional therapy for the treatment of PAD (Platelet antiaggregant, statin, cilostazol in case of claudication) and the other group of patients with conventional therapy for treatment of PAD plus cell therapy with objective to evaluate the microvascular effect after the application of cell therapy with a hematopoietic stem cell concentrate in patients with PAD with non-critical ischemia and Diabetes. Perform evaluations of the microcirculation by means of TcPO2 at 30, 60, 90 and 180 days after the experimental maneuver (cell therapy) and conventional therapy.
Read the detailed description
INTRODUCTION: Peripheral arterial disease (PAD) is defined as arterial occlusion of the lower extremities. Based on epidemiological studies using the Ankle-Brachial Index (ABI), the prevalence of PAD (defined as an ABI <0.9) in diabetic patients ranges from 20% to 30%. Diabetic patients with PAD have a higher mortality and death rate at a younger age than patients without diabetes. The appropriate medical treatment for EAP in patients with diabetes is based on the control of cardiovascular risk factors. Revascularization is indicated in particular situations in PAD in the context of critical chronic ischemia (ABI <0.6), however, anatomical factors, operative risk, technical difficulties or patient preferences may limit its use in patients with PAD and diabetes. Therapeutic angiogenesis is an experimental approach to restore perfusion and cell therapy can provide a continuous source of growth factors and structural elements for therapeutic angiogenesis. The transcutaneous oxygen pressure (TcPO2) is defined as a microvascular evaluation system. The microvascular effect of cell therapy at an earlier stage of PAD has not been analyzed as non-critical ischemia in patients with diabetes.
OBJECTIVE: To evaluate the microvascular effect after the application of cell therapy with a concentrate of hematopoietic stem cell in patients with PAD with non-critical ischemia and Diabetes.
MATERIAL AND METHODS: Randomized controlled clinical trial with blinding (for the observer who evaluates treatment goals). With two groups for your study. A group of patients with conventional therapy for the treatment of PAD (Platelet antiaggregant, statin, cilostazol in case of claudication) and the other group of patients with conventional therapy for treatment of PAD plus cell therapy, to be carried out in patients entitled to the Mexican Institute of the Social Security of the Guanajuato Delegation, with diagnosis of Diabetes Mellitus type 2 of more than 10 years of detection and with diagnosis of peripheral arterial disease with an ABI between 0.6 and 0.9 that agree to participate in the study. Cell therapy will consist of hematopoietic progenitor cells identified as a fraction of cells identified by flow cytometry as CD34 + obtained by peripheral blood harvesting procedure, prior mobilization process with filgrastim.
- Conditions
- Peripheral Arterial Disease, Diabetes Mellitus
- Being tested
- celular therapy
- Medical subject headings
- Peripheral Arterial Disease, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
celular therapyProcedure or surgery
application of cell therapy with a concentrate of hematopoietic progenitor cells or celular therapy
| Study group | Role | What they receive |
|---|---|---|
| conventional treatment | Placebo comparator | receive the best conventional therapy Receives: Procedure: celular therapy |
| experimental treatment | Active comparator | The best medical treatment possible plus celular therapy Receives: Procedure: celular therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
TcPO2
Change is being assessed, through the transcutaneous pressure of oxygen, after the application of the therapies
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start18 May 2018
- Primary completion18 May 2018
- Study completion27 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Treatment for peripheral arterial disease plus diabetes with 2 arms of study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Regional de Alta Especialidad del Bajio
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Mexicano del Seguro Social
- Responsible party
- Sponsor
- Investigators
- B MURILLO, MD, Study director, IMSS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03635970
- Sponsor's protocol ID
- CIBIUG-P14-2018
- Status last verified
- Aug 2020
- First submitted
- 6 Jul 2018
- Last updated
- 31 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Via email, the researchers can request information about study
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microvascular Effect After the Application of Cell Therapy With a Hematopoietic Stem Cell Concentrate in Patients With Peripheral Arterial Disease With Non-critical Ischemia and Diabetes
- ClinicalTrials.gov ID
- NCT03635970
- Acronym / sponsor ID
- CIBIUG-P14-2018
- Conditions
- Peripheral Arterial Disease, Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hospital Regional de Alta Especialidad del BajioUniversity, hospital or other
- Collaborators
- Instituto Mexicano del Seguro Social
- Study start
- 18 May 2018 (actual)
- Primary completion
- 18 May 2018 (actual)
- Study completion
- 27 Jul 2020 (actual)
- First posted
- 17 Aug 2018 (actual)
- 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.
This is a randomized controlled trial with blinding (for the observer who evaluates treatment goals).
With two groups to study. A group of patients with conventional therapy for the treatment of PAD (Platelet antiaggregant, statin, cilostazol in case of claudication) and the other group of patients with conventional therapy for treatment of PAD plus cell therapy with objective to evaluate the microvascular effect after the application of cell therapy with a hematopoietic stem cell concentrate in patients with PAD with non-critical ischemia and Diabetes. Perform evaluations of the microcirculation by means of TcPO2 at 30, 60, 90 and 180 days after the experimental maneuver (cell therapy) and conventional therapy.
Detailed description
INTRODUCTION: Peripheral arterial disease (PAD) is defined as arterial occlusion of the lower extremities. Based on epidemiological studies using the Ankle-Brachial Index (ABI), the prevalence of PAD (defined as an ABI <0.9) in diabetic patients ranges from 20% to 30%. Diabetic patients with PAD have a higher mortality and death rate at a younger age than patients without diabetes. The appropriate medical treatment for EAP in patients with diabetes is based on the control of cardiovascular risk factors. Revascularization is indicated in particular situations in PAD in the context of critical chronic ischemia (ABI <0.6), however, anatomical factors, operative risk, technical difficulties or patient preferences may limit its use in patients with PAD and diabetes. Therapeutic angiogenesis is an experimental approach to restore perfusion and cell therapy can provide a continuous source of growth factors and structural elements for therapeutic angiogenesis. The transcutaneous oxygen pressure (TcPO2) is defined as a microvascular evaluation system. The microvascular effect of cell therapy at an earlier stage of PAD has not been analyzed as non-critical ischemia in patients with diabetes.
OBJECTIVE: To evaluate the microvascular effect after the application of cell therapy with a concentrate of hematopoietic stem cell in patients with PAD with non-critical ischemia and Diabetes.
MATERIAL AND METHODS: Randomized controlled clinical trial with blinding (for the observer who evaluates treatment goals). With two groups for your study. A group of patients with conventional therapy for the treatment of PAD (Platelet antiaggregant, statin, cilostazol in case of claudication) and the other group of patients with conventional therapy for treatment of PAD plus cell therapy, to be carried out in patients entitled to the Mexican Institute of the Social Security of the Guanajuato Delegation, with diagnosis of Diabetes Mellitus type 2 of more than 10 years of detection and with diagnosis of peripheral arterial disease with an ABI between 0.6 and 0.9 that agree to participate in the study. Cell therapy will consist of hematopoietic progenitor cells identified as a fraction of cells identified by flow cytometry as CD34 + obtained by peripheral blood harvesting procedure, prior mobilization process with filgrastim.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Treatment for peripheral arterial disease plus diabetes with 2 arms of study.
| Arm | Type | Receives |
|---|---|---|
| conventional treatment | Placebo comparator | Procedure: celular therapyreceive the best conventional therapy |
| experimental treatment | Active comparator | Procedure: celular therapyThe best medical treatment possible plus celular therapy |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with affiliation to the Mexican Institute of Social Security.
- Patients older than 35 years.
- Patients with Type 2 Diabetes Mellitus over 10 years of detection.
- Patients with Peripheral Arterial Disease with ABI between 0.6 and 0.9.
- Signature of informed consent.
Key exclusion criteria (5 listed)
- Patients with a history of uncontrolled oncological disease in the last 5 years.
- Presence of Chronic Renal Insufficiency with a calculated creatinine clearance using a Cockcroft formula less than 15ml / min.
- Ulcer that defines diabetic foot or tissue necrosis that requires partial or total amputation of a limb.
- Serious active infectious process anywhere in the body.
- Have restrictions with the use of filgrastim such as treatment with lithium, chemotherapy or radiotherapy, as well as a history of autoimmune thrombocytopenia, vasculitis, previous cardiovascular disease, Sweet's syndrome or Steven-Johnson syndrome.
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 |
|---|---|---|
| celular therapyapplication of cell therapy with a concentrate of hematopoietic progenitor cells or celular therapy | Procedure or surgery | conventional treatment, experimental treatment |
Primary outcome
TcPO2
Time frame: 180 days
Change is being assessed, through the transcutaneous pressure of oxygen, after the application of the therapies
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 31 Aug 2020.
- Individual participant dataSharing planned: Yes. Via email, the researchers can request information about study
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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.
B MURILLO, MD study director
IMSS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing celular therapy in people with Peripheral Arterial Disease and Diabetes Mellitus, run by Hospital Regional de Alta Especialidad del Bajio 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 5 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 31 Aug 2020. 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. Some participants in this study may receive a placebo. 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 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?
TcPO2 (time frame: 180 days). 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 31 Aug 2020.