Ignite Creation Date:
2024-05-06 @ 12:24 AM
Last Modification Date:
2024-10-26 @ 10:49 AM
Study NCT ID:
NCT01564407
Status:
TERMINATED
Last Update Posted:
2017-07-11
First Post:
2011-12-20
Brief Title:
A Clinical Study of Allogeneic Human Dermal Fibroblasts for Remodeling Scar Contractures
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
A Phase III Clinical Study of Allogeneic Human Dermal Fibroblasts for Remodeling Scar Contractures
Status:
TERMINATED
Status Verified Date:
2017-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study Terminated due to lack of Funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 individuals 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 025 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 doctors 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
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 individuals 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 025 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 doctors 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None