Burn Scar Clinical Trial
Official title:
A Phase I/II Clinical Study of Allogeneic Human Dermal Fibroblasts for Remodeling Scar Contractures
The primary objective of this study is to evaluate the safety of ICX-RHY-013 in the
treatment of stable, restrictive scars in subjects who have suffered a burn injury.
Evaluation will be achieved through regular assessment of adverse events, vital signs, blood
work monitoring and laboratory analysis cellular properties of the scar through biopsy.
The secondary objectives of this study are to evaluate improvement in symptoms of scars
including reduced pain, discomfort and itching, improvement in mobility and daily function,
improvement in appearance and scar texture.
Restrictive scar contracture (a condition where tissue thickens and tightens, pulling the
surrounding healthy skin toward the damaged area) due to a serious burn injury can result in
long term aesthetic and physical consequences.
Skin contractures adjacent to a joint lead to joint deformities that severely restrict range
of motion (ROM) of the affected joint. Skin contractures are also often accompanied by
crippling levels of chronic pain resulting in a high level of dependency on pain
medications. These isolated or combined factors can lead to a significant disruption in both
social and professional life, leading to a marked impact on an individual's quality of life.
The current standard of care for restrictive scar contracture involves the surgical excision
of the contracture itself and/ or skin grafting. These standard therapies require extensive
and often repeated surgeries. Physicians are continually seeking less invasive therapies to
treat patients with burn contractures.
ICX‐RHY‐013 is an investigational medicinal product comprised of viable allogeneic human
dermal fibroblast (HDFs) cells suspended in HypoThermosol®-FRS. HDFs are isolated from
neonatal foreskin, cryopreserved, thawed and expanded in culture under good manufacturing
practice at Intercytex Ltd., United Kingdom. The drug formulation will be 20 million cells
per 1 milliliter of HypoThermosol® and will be administered to subjects via intradermal
injections at a maximum dose of 0.25 ml (or 5 million cells) per cm² of tissue.
If determined to be safe and effective, it is believed this therapy could, in the future, be
delivered in a series of superficial injections and can be carried out in a doctor's office.
This treatment could represent a new less invasive therapy of choice for patients with burn
contractures, where current recourse would be to surgery. This advance could have
significant positive benefits to the patient in terms of:
- no side-effects of surgery
- treatment given in an outpatient environment without the need for expensive
hospitalization
- enhanced quality of life
- lower costs
Cohort 1 will consist of 4 participants who are scheduled to have elective body contouring
surgery which will consist of the removal of an abdominal incision scar. The investigational
drug will be injected into the existing surgical incision (scar) with the investigational
drug, ICX-RHY-013. The purpose of this cohort is to evaluate the initial safety of the
investigational drug (ICX-RHY-013) in a series of doses on your surgical scar that will then
be surgically removed.
Cohorts 2 through 5 will consist of 4 participants each who have burn scars with restrictive
scar contractures. The purpose of these cohorts is to evaluate the ongoing safety of the
investigational drug (ICX-RHY-013) in post burn scars with restrictive scar contractures.
The investigational drug will be injected directly into these scar contractures. Each cohort
is unique in that the dose and frequency of the investigational drug received will be
different. We will evaluate the safety of the drug between each cohort by assessing all side
effects that the participants may experience.
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