ClinicalTrials.gg
RecruitingNCT05798962Updated Apr 6, 2023

Cellular Mechanisms Involved in Muscle Pathology

An observational study in Muscle Strain, Lower Leg, Muscle Strained Thigh and Achilles Tendon; Laceration, sponsored by Bispebjerg Hospital. Recruiting at 1 site in Denmark. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-06.

Sponsored by Bispebjerg Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Feb 2025, 1 year 8 months ago, but the record still lists the study as recruiting.
  • Started Apr 2023; still recruiting 3 years 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years and older
Sex
All
01

Study summary

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.
Read the detailed description

Skeletal muscle strain injury is one of the most common sports injuries, which is caused by excessive tensile strain of the muscle and affects the region where muscle fascicles insert into the connective tissue (aponeurosis). It is therefore not an injury solely affecting skeletal muscle, but the skeletal muscle-aponeurosis interface. Having sustained one strain injury increases the risk of re-injury substantially, changes the biomechanics of the involved muscle and leads to a significantly enlarged aponeurosis. Recently, the investigators have discovered the accumulation of ectopic fat in the intra-fascicular space and within myofibrils. The built-up of ectopic fat in skeletal muscle is a degenerative state and has mostly been described for rotator cuff injuries where it is associated with worse shoulder functional scores. At the same time, the investigators have observed a high cellularity in the pathologic muscle-aponeurosis following strain injuries, but it is not known what cell types these cells are. It seems therefore likely that at least some of the cells are Fibro/adipogenic progenitors (FAPs), which contribute to the fat accumulation in strain injured muscles and that fat accumulation might be a factor contributing to the high risk of recurrent injuries, as well as other medical problems such as pain and decreased function often described long time after a strain injury.

Another common injury of the lower leg is the full Achilles tendon rupture. Recent data show that patients have long-term impairments in the injured leg when compared to the non-injured side. Also after full Achilles tendon ruptures, fatty degeneration of the muscles in the calf has been reported and has been linked to poor patient outcome. Recently, the investigators have observed fatty infiltration of calf muscles in patients following Achilles tendon rupture, which might lead to a decrease in muscle function and thereby to a poor patient outcome.

Despite the high prevalence of muscle strain injuries, very little is known about the cellular mechanisms following a strain injury. In addition, the literature on the cellular composition and alterations following Achilles tendon ruptures is scarce. A decade ago, a group of cells named fibro/adipogenic progenitors (FAPs) have been identified in the interstitial space of skeletal muscle based on the presence of stem cell antigen 1+, CD34+, Platelet Derived Growth Factor Receptor α (PDGFR α)+ . Aside from their supporting activity in muscle regeneration, FAPs have the potential to adopt an adipogenic or profibrotic phenotype. Despite the high incidence, it has not been studied whether the traumatic injury and the subsequent biomechanical changes in the skeletal muscle and associated connective tissue following strain injuries or Achilles tendon rupture activate FAPs, and how these cells contribute to the fatty accumulation in the skeletal 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. The investigators 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.

To test this, the investigators will take small tissue samples from the injured area in either the acute phase (subject group A) or the chronic phase (subject group B) after a strain injury as well as from the muscle tissue of individuals who had a full Achilles tendon rupture at least a year prior to inclusion (subject group C). In all three groups, the investigators will also take a small tissue sample from the same muscle as the injured one on the healthy side. In addition, a larger muscle biopsy from the contralateral healthy vastus lateralis muscle is taken to compare the cellular composition and the cellular profile between the pathologic skeletal muscle-aponeurosis and a healthy skeletal muscle.

To test the importance of mechanical stimuli, isolated muscle cells will be sorted with Fluorescence Activated Cell Sorting (FACS) and cultured in vitro thereafter. The investigators particularly focus on culture under static and dynamic tension and in the de-tensioned state.

An alpha level of 0.05 will be considered significant. Based on previous data, 10 participants will be recruited for each group, enabling the investigators to detect an estimated doubling of FAPs in the injured muscles (primary outcome). Power analysis for the primary outcome resulted in n=4 for each group (α=0.05, β=0.80, CV=72.4%), which the investigators consider to be clinically relevant. The investigators plan to include 10 participants in each group to have sufficient biopsy material from 5 individuals for single nuclei RNA sequencing and 5 biopsies for fluorescence-activated cell sorting and the subsequent in vitro studies.

02

Conditions studied

  • Muscle Strain, Lower Leg
  • Muscle Strained Thigh
  • Achilles Tendon; Laceration
  • Fatty Degeneration
03

In context

Sprains and Strains

246 studies on the registry are indexed under Sprains and Strains; 49 are open to participants now.

This study's planned enrollment of 30 is below the median of 101 across 79 observational studies indexed under Sprains and Strains.

Browse Sprains and Strains studies →

Lead sponsor

Bispebjerg Hospital is the lead sponsor of 289 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Healthy individuals with an acute or previous muscle strain injury or a previous Achilles tendon rupture

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 18 years and older, male and female, with an acute muscle strain injury (\<14 days post injury) in the calf or hamstring muscles (group 1). Pathological changes visible on an ultrasound scan as hypoechoic areas.
  • 18 years and older, male and female, with a chronic muscle strain injury (> 6 months prior to inclusion) in the calf or hamstring muscles (group 2), sequela including recurrent strain injuries, pain and/ or decrease in muscle function. Pathological changes visible on an ultrasound scan as hypo-/ hyperechoic areas.
  • 18 years and older, male and female, with a full Achilles tendon rupture (> 1 year prior to inclusion) with pathological changes: Fatty degeneration visible on an ultrasound scan (group 3).

Exclusion criteria

Exclusion Criteria:

  • Type I and II Diabetes, Connective tissue and/or rheumatic diseases, or any observed organ dysfunctions
  • Daily smoking
  • Persons with daily intake of non-steroidal anti-inflammatory drugs (NSAIDs) within three months prior to time of contact
  • Allergic reactions to local anesthesia
  • Use of anticoagulant treatment
  • Needle phobia
  • Any drug or alcohol abuse now or in the past
  • The absence of any pathological changes visible on an ultrasound scan as hypo-/ hyperechoic areas (group 1 and 2)
  • The absence of any pathological changes (fatty degeneration) in either the gastrocnemius or the soleus muscle visible on an ultrasound scan (Subject group 3)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Acute muscle strain

    Subjects with an acute muscle strain (within 14 days post injury) in either the hamstrings or the calf muscles

    Procedure: Biopsies

  • Chronic muscle strain

    Subjects with a chronic muscle strain more than 6 months prior to inclusion in either the hamstrings or the calf muscles

    Procedure: Biopsies

  • Achilles tendon rupture

    Subjects with a full Achilles tendon rupture more than 12 months prior to inclusion

    Procedure: Biopsies

Interventions

  • ProcedureBiopsies

    Biopsies from the pathological muscle and healthy, unaffected muscle

06

What researchers measure

Primary outcomes

  1. Presence and number of Fibro-adipogenic progenitors

    Determination of the number and the phenotypic appearance of fibro-adipogenic progenitors in the injured compared to the healthy muscle

    Time frame: 2 years: Sampling and analyses

Secondary outcomes

  1. Cell cluster analysis

    Analysis of cell clusters present in the injured compared to the healthy muscle by single nuclei RNA sequencing

    Time frame: 2 years: Sampling and analyses

  2. Importance of mechanical stimuli for Fibro-adipogenic progenitors

    Importance of mechanical stimuli on the phenotypic drift of fibro-adipogenic progenitors ("FAPS". Isolated FAP´s will be subjected to either mechanical stimulation (by using the FlexCell system) or unloading ("FAPs embedded in a free-floating matrix). FAPs will also be cultured on stiff versus soft surfaces to study thereafter the effect of the substrate properties on the phenotypic appearance of FAPs. The phenotypic appearance of FAPs will be tested by qRT-PCR, protein analysis and compared to the well-described effect on phenotypic apprearance of FAPs when subjected to pro-fibrotic or pro-adipogenic differentiation medium.

    Time frame: 2 years: Sampling and analyses

07

Study locations

1 of 1 sites recruiting
  • Institute of Sports Medicine Copenhagen, Bispebjerg Hospital, Nielsine Nielsen Vej 11, Building 8
    Copenhagen, 2400, Denmark
    Recruiting
08

References and documents

Publications

  • Bayer ML, Hoegberget-Kalisz M, Jensen MH, Olesen JL, Svensson RB, Couppe C, Boesen M, Nybing JD, Kurt EY, Magnusson SP, Kjaer M. Role of tissue perfusion, muscle strength recovery, and pain in rehabilitation after acute muscle strain injury: A randomized controlled trial comparing early and delayed rehabilitation. Scand J Med Sci Sports. 2018 Dec;28(12):2579-2591. doi: 10.1111/sms.13269. Epub 2018 Aug 16. PubMed 30043997 ↗
  • Ekstrand J, Walden M, Hagglund M. Hamstring injuries have increased by 4% annually in men's professional football, since 2001: a 13-year longitudinal analysis of the UEFA Elite Club injury study. Br J Sports Med. 2016 Jun;50(12):731-7. doi: 10.1136/bjsports-2015-095359. Epub 2016 Jan 8. PubMed 26746908 ↗
  • Bayer ML, Hoegberget-Kalisz M, Svensson RB, Hjortshoej MH, Olesen JL, Nybing JD, Boesen M, Magnusson SP, Kjaer M. Chronic Sequelae After Muscle Strain Injuries: Influence of Heavy Resistance Training on Functional and Structural Characteristics in a Randomized Controlled Trial. Am J Sports Med. 2021 Aug;49(10):2783-2794. doi: 10.1177/03635465211026623. Epub 2021 Jul 15. PubMed 34264782 ↗
  • Gladstone JN, Bishop JY, Lo IK, Flatow EL. Fatty infiltration and atrophy of the rotator cuff do not improve after rotator cuff repair and correlate with poor functional outcome. Am J Sports Med. 2007 May;35(5):719-28. doi: 10.1177/0363546506297539. Epub 2007 Mar 2. PubMed 17337727 ↗
  • Uezumi A, Fukada S, Yamamoto N, Takeda S, Tsuchida K. Mesenchymal progenitors distinct from satellite cells contribute to ectopic fat cell formation in skeletal muscle. Nat Cell Biol. 2010 Feb;12(2):143-52. doi: 10.1038/ncb2014. Epub 2010 Jan 17. PubMed 20081842 ↗
  • Uezumi A, Ito T, Morikawa D, Shimizu N, Yoneda T, Segawa M, Yamaguchi M, Ogawa R, Matev MM, Miyagoe-Suzuki Y, Takeda S, Tsujikawa K, Tsuchida K, Yamamoto H, Fukada S. Fibrosis and adipogenesis originate from a common mesenchymal progenitor in skeletal muscle. J Cell Sci. 2011 Nov 1;124(Pt 21):3654-64. doi: 10.1242/jcs.086629. Epub 2011 Nov 1. PubMed 22045730 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2023 (actual). Primary completion is estimated for Feb 2025, 22 months after the start.

Of 36 observational studies under Sprains and Strains, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 36. This study's planned 22 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 27, 2023
First posted
Apr 5, 2023
StartActual
Apr 5, 2023
Primary completionEst.
Feb 28, 2025
CompletionEst.
Aug 31, 2030
Last update
Apr 6, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05798962
Responsible party
Monika Lucia Bayer (Senior Researcher, Bispebjerg Hospital) — Principal investigator
First posted
Apr 5, 2023
Start date
Apr 5, 2023
Primary completion
Feb 28, 2025 (estimated)
Completion
Aug 31, 2030 (estimated)
Last update
Apr 6, 2023

Study contacts

Monika L Bayer, PhD
Contact
Monika.lucia.bayer@regionh.dk
004525687931
Michael Kjaer, DMSci
Contact
michaelkjaer@sund.ku.dk
004538636022
Monika L Bayer, PhD
principal investigator · Bispebjerg Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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