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Coronary Atherosclerosis and Other Heart DiseasePhase 2/3NCT02022514

Intracoronary Infusion of Mononuclear Cells Autologous Bone Marrow in Patients With Chronic Coronary Occlusion and Ventricular Dysfunction, Previously Revascularized.

A Phase 2/3 study testing Mononuclear cells from autologous bone marrow and Conventional medical treatment in people with Coronary Atherosclerosis and Other Heart Disease, run by Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud at 2 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Clinical trial phase III, prospective, controlled, randomized, open. We hypothesize work that patients with chronic coronary occlusion and poor myocardial viability who failed to recover ventricular function after subjecting coronary revascularization with new techniques of recanalization, could achieve an improvement… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Mononuclear cells from autologous bone marrow and Conventional medical treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
2 sitesSpain
Study dates
Nov 2013to Aug 2023
Phase
Phase 2/3
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

  • Patients who give their informed consent to participate in this clinical trial.
  • Patients of both sexes with atherosclerotic coronary artery disease and chronic occlusions that recanalization has been achieved successfully implanted medicated stents, and in which nevertheless persists ventricular dysfunction evaluated by magnetic resonance.
  • Aged between 18 and 80 years.
  • Magnetic resonance performed at least 3 months of recanalization, the ejection fraction patient should remain below or iqual to 45%.
  • Normal renal function or mild renal insufficiency with serum creatinine exceeding 2.5 mg / dl.
  • Normal hepatic transaminases values function < 2,5 times the upper limit of the normal range.
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  • Hemogram and coagulation studies were within normal values, defined by:
  • Leucocytes ≥ 3000
  • Neutrophils ≥ 1500
  • Platelets ≥ 100000
  • Hemoglobin > 10g/dl
  • Blood pregnancy test with negative results in the case of patients of childbearing age.
  • Acceptance by patients (both men and women) of childbearing age to use safe contraceptive methods throughout the study, including the six month follow-up.
  • Willingness and ability to implement the program of visits, treatment plan, laboratory tests, and all study procedures.

Who cannot join

  • Patients with chronic occlusions that recanalization were not achieved successfully.
  • Patients with ejection fractions upper to 45% after 3 months of recanalization.
  • Positive serology for HIV, HCV or HBV.
  • Coexistence of other serious systemic diseases or contraindication for double antiaggregation (clopidogrel and aspirin).
  • Coexistence of any type of hematological disease.
  • Pregnant, breast-feeding, or women of childbearing age who are not using effective contraception. A woman of childbearing age is considered to be all women from the age of 18 and up to one year after the last menstruation in the case of menopausal women.
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  • Patients who are currently participating or have completed their participation in a clinical trial within a period of less than 3 months or who have participated in a clinical trial of Advanced Therapies (cell therapy, gene therapy or tissue engineering) at any time before and has been assigned to an experimental group.
  • Patients with malignant or pre-malignant tumors.
  • Patients in whom an MRI cannot be performed because they carry devices incompatible with the MRI (prostheses, defibrillators, pacemakers, etc).

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

  • Dr. Alejandro Gutierrez

    Cadiz, 11009

  • Hospital U. Reina Sofía

    Seville, 14004

Other trials in Spain

About this study

Official title: Phase III Clinical Trial, Multicentric, Open, Randomized and Controlled to Assess the Effectiveness of Intracoronary Infusion of Mononuclear Cells Autologous Bone Marrow in Patients With Chronic Coronary Occlusion and Ventricular Dysfunction, Previously Revascularized.

Clinical trial phase III, prospective, controlled, randomized, open.

We hypothesize work that patients with chronic coronary occlusion and poor myocardial viability who failed to recover ventricular function after subjecting coronary revascularization with new techniques of recanalization, could achieve an improvement of ventricular function if given further regenerative treatment with mononuclear cells from autologous bone marrow.

To test this hypothesis we designed a prospective, randomized clinical trial in patients with recanalized chronic occlusions and ventricular dysfunction.

Read the detailed description

This is a randomized, open label prospective clinical trial in which all patients diagnosed with chronic coronary occlusion in the Cardiology Department of Hospital Reina Sofía in Cordoba and Hospital Puerta del Mar in Cadiz, who meet inclusion criteria and none of the exclusion shall include and express their accordance with trial participation by signing the informed consent.

66 patients who did not improve ventricular function measured by Magnetic resonance at least 3 months after revascularization of chronic coronary occlusion will be included . The 66 patients will be randomized in one to one ratio to an intervention group that received bone marrow mononuclear cells by intracoronary autologous (0.5 to 1 x 10 9 total cells) and a control group who receive only conventional medical treatment. The two groups of patients will be followed, in the clinical trial, for 6 months. Once the test is complete, they will follow according to standard clinical practice of Cardiology hospital for at least 24 months.

Patients will be assessed by clinical and Magnetic resonance methods. All patients will be medically treated similarly with ACE inhibitors or angiotensine 1 receptor (AT1) receptor antagonists of angiotensin II, beta-blockers and diuretics.

The main objective os the study is to determine the efficacy of intracoronary infusion of mononuclear cells from autologous bone marrow in patients with chronic coronary occlusion previously revascularized with stents in terms of improved ventricular function determined by magnetic resonance.

Secondary objectives of the study are:

  1. To confirm, in view of the obtained results, the suitability of the proved protocol for the treatment of chronic coronary occlusion.
  2. To study changes in functional class (I-IV NYHA) of these patients compared with the control group.
  3. To evaluate the safety of treatment, the analysis of possible cardiac events during the 6-month follow-up in the clinical trial and 24 months of additional clinical follow-up (death, myocardial infarction, repeat revascularization) compared with the control group.
Being tested
Mononuclear cells from autologous bone marrow, Conventional medical treatment
Medical subject headings
Coronary Artery Disease

What participants receive

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

  • Mononuclear cells from autologous bone marrowOther

    Mononuclear bone marrow cells autologous intracoronary

  • Conventional medical treatmentDrug

Study groups in NCT02022514
Study groupRoleWhat they receive
Mononuclear cells from autologous bone marrowExperimentalMononuclear bone marrow cells autologous intracoronary
Receives: Other: Mononuclear cells from autologous bone marrow
Conventional medical treatmentActive comparatorConventional medical treatment
Receives: Drug: Conventional medical treatment

What is being measured

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

  1. The primary endpoint will be the change in ejection fraction measured by magnetic resonance between inclusion and at 6 months follow-up

    Measured: 6 months

Secondary outcomes (4)

  1. Changes of NYHA functional grade comparative manner between the groups.

    Measured: 6 months

  2. Possible cardiac events during follow-up (death, myocardial infarction, repeat revascularization).

    Measured: 6 months

  3. Need for hospital admission or presence of major arrhythmia

    Measured: 6 months

  4. Changes in global and segmental left ventricular function

    Measured: 6 months

Timeline

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

  1. First posted27 Dec 2013 (estimated)
  2. Study startNov 2013
  3. Primary completionAug 2023
  4. Study completionAug 2023

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02022514
Sponsor's protocol ID
CMMo/OCC/2012
Status last verified
Nov 2023
First submitted
20 Dec 2013
Last updated
8 Nov 2023
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Mononuclear cells from autologous bone marrow and Conventional medical treatment in people with Coronary Atherosclerosis and Other Heart Disease, 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 14 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: finished, as of the sponsor's last update on 8 Nov 2023. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

The primary endpoint will be the change in ejection fraction measured by magnetic resonance between inclusion and at 6 months follow-up (time frame: 6 months). 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 NCT02022514.

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 8 Nov 2023.

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