NCT05798962

Cellular Mechanisms Involved in Muscle Pathology

Recruiting now Last updated 6 April 2023

What this trial tests

trial testing Biopsies in Muscle Strain, Lower Leg in 30 participants. Currently enrolling.

Timeline

5 April 2023

Primary endpoint
28 February 2025

31 August 2030

Quick facts

Lead sponsor	Bispebjerg Hospital
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	30
Start date	5 April 2023
Primary completion	28 February 2025
Estimated completion	31 August 2030
Sites	1 location across Denmark

Drugs / interventions tested

• Biopsies — full drug profile →

Conditions studied

• Muscle Strain, Lower Leg — all drugs for Muscle Strain, Lower Leg →
• Muscle Strained Thigh — all drugs for Muscle Strained Thigh →
• Achilles Tendon; Laceration — all drugs for Achilles Tendon; Laceration →
• Fatty Degeneration — all drugs for Fatty Degeneration →

Sponsor

Bispebjerg Hospital

Who can join

18 and older, any sex, with Muscle Strain, Lower Leg or Muscle Strained Thigh. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The overall purpose of this proposed study is the understanding of cellular mechanisms involved in the pathologic fatty degeneration of muscle. Fatty infiltration in skeletal muscle is observed following sports injuries such as muscle strain injuries and Achilles tendon rupture. It is also observed in the degenerative state after rotator cuff tears as well as in the aging process. While fatty degeneration of skeletal muscle occurs in many different conditions and is known to decrease muscle function, the cellular processes involved in fatty infiltration have not been investigated in human muscle.

Hypotheses:

1. There is a high amount of fibro-adipogenic progenitors (FAPs) with an adipogenic pattern in pathologic skeletal muscle following a muscle strain injury and a full Achilles tendon rupture. We hypothesize that there is an increased number of FAPs with an adipogenic signature already in the acute phase after a strain injury, but a significantly higher number in the chronic stage as well as in the muscle following an Achilles tendon rupture.
2. Mechanical cues are a major driver of the phenotypic drift of FAPs. The lack of mechanical stimuli initiates the adoption of an adipogenic pathway in naïve FAPs, whereas naïve FAPs exposed to mechanical stimuli will maintain their undifferentiated phenotype.
3. The adherence of FAPs to a soft material will activate the adoption of an adipogenic phenotype, whereas a stiff material will favor a more fibrotic phenotype in naïve FAP's isolated from healthy skeletal muscle.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.