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Control of the Opening of mPTP by Ex Vivo Measurements on Permeabilized Muscle Fibers (COMMEF) (COMMEF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04209413
Recruitment Status : Recruiting
First Posted : December 24, 2019
Last Update Posted : January 22, 2020
CRNH Auvergne
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Brief Summary:

mPTP (Mitochondrial Permeability Transition Pore) is a channel formed by a protein complex integrated into the inner membrane of mitochondria. Its opening is related to the elevation of the intra-mitochondrial calcium concentration and will result in: a mitochondrial decoupling, a rupture of the metabolic gradient and the release of pro-apoptotic factors.

The objective of this study is the development of a new ex vivo technique for characterizing mPTP by a dual measurement combining oxygraphy and fluorimetry on permeabilized skeletal muscle fibers.

Condition or disease Intervention/treatment
Anterior Cruciate Ligament Injuries Procedure: Patients referred for a knee ligamentoplasty

Detailed Description:

The development of new expertise in the study of mPTP is part of an approach to optimize the processing of muscle samples. The aim of this work is to evaluate the feasibility and reproducibility of a method of analysis on muscle fibers only permeabilized, while coupling two complementary techniques, oxygraphy and fluorimetry. Its principle is based on the knowledge that the opening of the mPTP leads to an inhibition of respiration at the level of the complex I of the respiratory chain. This inhibition is the consequence of the escape from mitochondria of the reduced form of nicotinamide adenine dinucleotide (NADH, i.e. substrate of complex I) concomitant with the opening of mPTP. Thus, the oxygraphy must allow the observation of the inhibition of respiration synonymous with the non-availability of the substrate of the complex I and thus indirectly reflect the opening of the mPTP. For its part, the fluorimetry must allow, in the presence of a fluorescent calcium indicator (i.e. Calcium Green), the observation of the release of calcium synonymous with the opening of the mPTP.

Once validated, this technique should make it possible to evaluate in situ the sensitivity of mPTP to calcium. In a context of application within clinical protocols, the evaluation of the mPTP calcium sensitivity should contribute to a better understanding of the physiological and physio-pathological mechanisms of adaptation of muscle tissue.

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Other
Time Perspective: Other
Official Title: Control of the Opening of mPTP by Ex Vivo Measurements on Permeabilized Muscle Fibers
Actual Study Start Date : January 20, 2020
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber

Intervention Details:
  • Procedure: Patients referred for a knee ligamentoplasty
    knee ligamentoplasty

Primary Outcome Measures :
  1. Determination of the mPTP calcium sensitivity mPTP [ Time Frame: day 0 ]
    The goal is to study the feasibility of a new method for the analysis of the calcium sensitivity of mPTP on non-phantomized permeabilized muscle fibers by coupled use of oxygen and fluorimetry techniques. Calcium quantity and time required to open mPTPs in permeabilized muscle fibers will be measured, in the presence or absence of ciclosporin A, observable by total inhibition of mitochondrial respiration (synonymous with release of NADH).

Secondary Outcome Measures :
  1. Identification of mPTP opening discrimination factors [ Time Frame: Day 0 ]
    Evaluate the possibility of population discrimination by this new method of analysis (i.e. variability by age and duration of functional impotence before intervention of the amount of calcium required to open the mPTP).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients referred for a knee ligamentoplasty

Inclusion Criteria:

  • Patients aged over 18 ;
  • Patients referred for a knee ligamentoplasty (DIDT technique) ;
  • Patients who signed the non-opposition form after being informed ;
  • Patients benefiting from or affiliated to a social security.

Exclusion Criteria:

- Patients under guardianship, curatorship or deprived of liberty.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04209413

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Contact: Lise LACLAUTRE +334.73.754.963

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CHU de Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63000
Contact: Ruddy Richard   
Principal Investigator: Ruddy Richard         
Sub-Investigator: Stéphane Descamps         
Sub-Investigator: Stéphane Boisgard         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
CRNH Auvergne
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Principal Investigator: Ruddy Richard University Hospital, Clermont-Ferrand
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Responsible Party: University Hospital, Clermont-Ferrand Identifier: NCT04209413    
Other Study ID Numbers: RNI 2019 RICHARD
2019-A01109-48 ( Other Identifier: ANSM )
First Posted: December 24, 2019    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Clermont-Ferrand:
Anterior Cruciate Ligament operation
Skeletal muscle
Mitochondrial permeability transition pore opening (mPTP opening)
Additional relevant MeSH terms:
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Anterior Cruciate Ligament Injuries
Knee Injuries
Leg Injuries
Wounds and Injuries