IGF-I Stimulation of Collagen Synthesis in Ehlers-Danlos Patients

What Was Tested

In this not phased trial, researchers set out to test Mecasermin (rhIGF-1).

The investigators want to inject insulin-like growth factor-I (IGF-I) into the patella tendon of Ehlers-Danlos patients and healthy controls to evaluate the response in collagen synthesis.

Furthermore collagen synthesis is measured in muscle connective tissue and in skin.

The hypothesis is that the connective tissue in Ehlers-Danlos patients is more compliant and poorer in collagen than healthy controls, but that collagen synthesis can be stimulated by IGF-I.

It had four arms (groups): mecasermin + Ehlers-Danlos (active comparator), Saline + Ehlers-Danlos (placebo comparator), Mecasamin + healthy control (active comparator) and Saline + healthy control (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

IGF-I will be injected with ultrasound guidance to one patella tendon and the other one will be injected with saline as control.

Injections will be performed double blinded and timed 24 hours and 6 hours before tissue sampling.

Collagen synthesis will be measured as fractional synthesis rate based on stabile isotope technique using labelled proline. 10 patients diagnosed with Classical form of Ehlers-Danlos syndrome will be included and matched with 10 healthy controls based on age, gender, BMI and activity level.

The muscle biopsy will be taken from vastus lateralis muscle and the skin biopsy from the buttocks.

Who Took Part

Enrollment: 15 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Classic form of Ehlers-Danlos syndrome OR healthy matched control.

The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: malignity, cardiac diseases, diabetes, tendinopathy in patella tendons.

How the Study Was Run

The set-up was randomized, factorial and double-blind.

Random assignment meant chance, not the researchers, decided who got Mecasermin (rhIGF-1) and who got the comparison, which limits bias.

Neither the participants nor the staff measuring them knew who was on Mecasermin (rhIGF-1), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2011-09 with completion listed for 2012-11.

It ran at 1 site in Denmark.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Fractional synthesis rate of collagen in tendon, muscle and skin (time frame: 6 hours).

It also tracked 2 secondary outcomes, for example Electron microscopy and mRNA.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Mecasermin (rhIGF-1) in 15 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Mecasermin (rhIGF-1) compound page, all human trials.