Rare diseases
Investigational molecules
Locations
Fibrin matrix is a polymer-based substance. In the registry records of the two trials presented here, it is classified as a surgical aid under the ATC code S01KX, which stands for "other surgical aids".[1][2] The product name under which it appears in these trials is ENDORET-PRGF (PRGF stands for Plasma Rich in Growth Factors).[1][2] Fibrin matrix is an investigational substance: the product records show no marketing authorisation, and the authorisation holder listed is Fundacio Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.[1][2]
Fibrin-based materials are also known from other medical contexts. A public summary from a risk management plan describes fibrin sealants, also called "fibrin glues", as products used to help close and heal wounds, with the goal of reducing the need for sutures and staples.[3] The same source notes that fibrin glues may be used to help heal and join tissues in cosmetic surgery, reconstructive surgery, and burn surgery, and to help stop bleeding on surfaces just under the skin.[3]
The mechanism of action of fibrin matrix is not described in the trial records. The supplementary sources provide general information about fibrin-based materials. A scientific article on platelet-rich fibrin-based matrices describes their use in tissue engineering, where they are studied for their ability to support the formation of new blood vessels, a process called angiogenesis, in a laboratory co-culture model for bone tissue engineering.[4] A public summary explains that fibrin glues help wounds heal so that sutures and staples will not be needed as much, if at all.[3]
In the two trials, fibrin matrix is given as a solution for injection. The pharmaceutical form is listed as solution for injection, and the route of administration is also solution for injection.[1][2] The intervention is described as ENDORET-PRGF, 1 unit, solution for injection.[1][2]
Two clinical trials are registered for fibrin matrix as the test substance, both authorised and both interventional.[1][2] The larger trial is a randomised low-intervention study in pterygium with 110 participants. It evaluates the efficacy of fibrin membrane graft with eye drops concentrated in autologous growth factors compared to amniotic membrane graft.[1]
The smaller trial is a phase 2 study in glaucoma with 30 participants. It assesses changes in tear osmolarity after topical treatment with PRGF.[2]
The pterygium trial measures recurrence rate, defined as the number of recurrences per technique divided by the surgeries performed with amniotic membrane implant and those using fibrin-rich growth factor graft. Recurrence is understood as the appearance of fibrovascular proliferation invading the corneal limbus and the cornea. This is evaluated during follow-up at one month, two months, three months, six months, and one year after the intervention.[1]
The glaucoma trial measures tear osmolarity using the Tearlab system, which collects a 30-nanoliter tear sample with a microchip for immediate results. The difference in tear osmolarity between baseline (V0) and a later visit (V2) is evaluated. Tear osmolarity was chosen as the primary variable because its increase, called hyperosmolarity, has been shown to be the best standalone clinical sign for diagnosing ocular surface pathology.[2]
The trial records do not list side effects. The supplementary sources do not provide a side effect profile for fibrin matrix as studied in these trials. A public summary on fibrin glues describes their use in surgery but does not report specific side effects for this substance.[3]
Each condition opens its own overview and trial list
Recruiting trials first
Tell us about your condition – we search every trial in Europe and connect you with the right site.
