Clinical trial NCT01564407
Conditions: Restrictive Scar Contracture Restrictive Hypertrophic Scar Burn Scar Contractures Burn Scar
Keywords: ICX-RHY-013 Restrictive scar contracture Restrictive hypertrophic scar Burn Scar Burn Scar contractures Scar
Sponsor: University of Pittsburgh
Start date: 2011-01-01; Completion date: 2014-02-01
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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.

Detailed description:
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.

Arms: arm 1: Stable restrictive scar contractures resulting from abdominal surgical incision, not transversing a joint. The minimum scar length of 7 cm and a maximum scar area size of 80cm². The scar is divided into five injection areas with a minimum of 0.5 cm uninjected areas between the 5 sites.Drug Dosing for Cohort 1:

1. Empty control no injection
2. Vehicle only (0.5 ml of HypoThermosol solution)
3. 5 million cells / cm² , single administration at Day 0
4. 5 million cells/ cm² , single administration at week 4
5. 5 million cells/cm² , single administration at Day 0 , repeat administration of this dose @ week 4 Subjects in Cohort 1 will undergo elective surgeries, at which time the treated scars will be removed, at week 6-8 post-treatment of the first dosed subject. arm 2: Participants receive intervention treatment of 2.5 million cells/ cm2, single administration injected into the scar. arm 3: Participants receive intervention treatment of 5 million cells /cm2, single administration arm 4: Participants receive intervention treatment of 2.5 million cells/ cm2, repeat dose administration @ 4 weeks arm 5: Participants receive intervention treatment of 5 million cells / cm2 repeat dose administration @ 4 weeks
Interventions: intervention 1: ICX-RHY-013
Intervention descriptions: intervention 1: Drug Dosing for Cohorts as follows:

Cohorts (N=4)

Safety Cohort 1:

1. Empty control no injection
2. Vehicle only (0.5 ml of HypoThermosol solution)
3. 5 million cells / cm² , single administration at Day 0
4. 5 million cells/ cm² , single administration at week 4
5. 5 million cells/cm² , single administration at Day 0 , repeat administration of this dose @ week 4

At day 0, the subject will receive a total of 3 different injections and at week 4 the subject will receive a total of 2 different injections.

Cohort 2: 2.5 million cells/ cm2, single administration Cohort 3: 5 million cells /cm2, single administration Cohort 4: 2.5 million cells/ cm2, repeat dose administration @ 4 weeks Cohort 5: 5million cells / cm2 repeat dose administration @ 4 weeks

Protocol documents: