Restrictive Scar ContracturePhase 1/2NCT01564407
A Clinical Study of Allogeneic Human Dermal Fibroblasts for Remodeling Scar Contractures
A Phase 1/2 study testing ICX-RHY-013 in people with Restrictive Scar Contracture and Restrictive Hypertrophic Scar, run by University of Pittsburgh at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Restrictive Scar Contracture, Restrictive Hypertrophic Scar, Burn Scar Contractures
- What is being tested?
- ICX-RHY-013
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Feb 2014
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects who are male or female, military or civilian, age 18 to 65 years of age and able to provide informed consent
- Subjects who have suffered an injury which has occurred no less than 6 weeks prior to their screening date which has resulted in a stable restrictive scar contracture
- Stable restrictive scar contracture that has resulted from abdominal surgical incision and does not transverse a joint (Cohort 1 only).
- Stable restrictive scar contracture has resulted from a burn injury and may transverse a joint (Cohorts 2-5 only)
- Subjects will have a minimum scar length of 7 cm and a maximum scar area size of 80cm² (Cohort 1 only)
- Subjects will have a minimum scar area size of 1cm² and a maximum scar area size of 80cm² (Cohort 2-5 only).
- Subjects who are, in the opinion of the Investigator, able to understand the study, comply with the study design and are willing to return to the clinic for all the research required follow-up visits
Who cannot join
- Subjects with previous use of cellular therapy (e.g. Isolagen) in the treatment area
- Subjects with a known history of keloids
- Subjects with a known history of bleeding disorders
- Subjects who have facial restrictive scar deficits, not to exclude the neck area.
- Subjects who have had contracture-release procedures in the treatment area within the previous six months
- Subjects with a known allergy to any of the constituents of HypoThermosol-FRS
Show all 23Show fewer
- Subjects taking immunosuppressive therapy including systemic steroids will be excluded if they have received any dose >7.5 mg of prednisone equivalent/day for more than one week within 90 days of the first treatment or planning immunosuppressive therapy at any time during the study (Intranasal/inhaled steroids are acceptable)
- Diagnosis of cancer within last 12 months and /or actively receiving chemotherapy or radiation treatment
- Subjects with a life expectancy of <9 months, terminal conditions or factors making follow-up difficult (e.g. no fixed address, telephone etc)
- Subjects with a history of hypersensitivity to additional study-associated drugs/therapies (e.g. isopropyl alcohol, EMLA cream, adrenaline, lidocaine, etc)
- Subjects with planned major surgical intervention during the course of the study.
- Subjects with known idiopathic or drug-associated coagulopathy
- Subjects taking medicinal products known to reduce hemostasis (e.g. heparin, Coumadin, etc.) in the 2 weeks prior to commencing treatment or planning to take medicinal products known to reduce hemostasis during the 12 week study period
- Subjects who have taken any other investigational product within 30 days prior to screening or planned use of any other investigational product during the study period.
- Subjects who are pregnant, lactating, planning pregnancy and women of child-bearing potential who are not abstinent or practicing an acceptable means of contraception, as determined by the Investigator, for the duration of the treatment phase
- Subjects with abnormal blood biochemistry or any other abnormal laboratory finding considered clinically significant in that it would deem the subject inappropriate for surgical procedures, as determined by the investigator (i.e. CBC with Differential, platelets, comprehensive metabolic panel to include electrolytes, bun/creatinine, liver function test and coagulation tests).
- Subjects who have, as determined by the investigator a history or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, or other condition that would preclude participation in the study (i.e. Type 1 and Type 2 diabetic patients) or any condition within the last 14 days requiring hospitalization or surgical intervention.
- Subjects with evidence of any past or present clinically significant medical condition that would impair wound healing
- Subjects with a known hypersensitivity to gentamycin, amphotericin B, Bovine serum or porcine products.
- Subjects with known alcohol or narcotic drug dependency
- Subjects with diagnosed autoimmune disorders known to affect wound healing, such as Systemic Lupus Erythematosis (SLE), psoriasis, infection and inflammation (seborrheic dermatitis).
- Subjects receiving an immunosuppressive medication regime including transplant anti-rejection agents.
- Subjects with an Axis II to diagnosis DSM-IV (e.g., Schizophrenia, Bipolar Disorder). Subjects who are found to be stable on medication and receive psychiatric clearance could be eligible for study participation per the Physician's discretion
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
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.
Read the 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.
- Conditions
- Restrictive Scar Contracture, Restrictive Hypertrophic Scar, Burn Scar Contractures, Burn Scar
- Being tested
- ICX-RHY-013
- Keywords
- ICX-RHY-013, Restrictive scar contracture, Restrictive hypertrophic scar, Burn Scar, Burn Scar contractures, Scar
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICX-RHY-013Drug
Also called Allogeneic human dermal fibroblasts
Drug Dosing for Cohorts as follows:
Cohorts (N=4)
Safety Cohort 1:
- Empty control no injection
- Vehicle only (0.5 ml of HypoThermosol solution)
- 5 million cells / cm² , single administration at Day 0
- 5 million cells/ cm² , single administration at week 4
- 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
| Study group | Role | What they receive |
|---|---|---|
| Safety Cohort | Experimental | 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. Receives: Drug: ICX-RHY-013 |
| 2.5M cells/cm2 | Active comparator | Participants receive intervention treatment of 2.5 million cells/ cm2, single administration injected into the scar. Receives: Drug: ICX-RHY-013 |
| 5M cells/cm2 | Active comparator | Participants receive intervention treatment of 5 million cells /cm2, single administration Receives: Drug: ICX-RHY-013 |
| 2.5M cells/cm2 at 4 weeks | Active comparator | Participants receive intervention treatment of 2.5 million cells/ cm2, repeat dose administration @ 4 weeks Receives: Drug: ICX-RHY-013 |
| 5M cells/cm2 at 4 weeks | Active comparator | Participants receive intervention treatment of 5 million cells / cm2 repeat dose administration @ 4 weeks Receives: Drug: ICX-RHY-013 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
The evaluation of safety of ICX-RHY-013 in the treatment of stable, restrictive hypertrophic scars through assessment of adverse events. The primary objective of the safety (no injection) cohort is to evaluate initial safety of multiple doses through assessment of adverse events. The primary objective of remaining cohorts is to evaluate the ongoing safety of ICX-RHY-013 in post-burn hypertrophic scars that are not planned for excision through assessment of adverse events.
Measured: Days 0, 7, 14, 28, 56, 84
Number of Participants With Serious Adverse Events Reported
The evaluation of tolerability of ICX-RHY-013 in the treatment of stable, restrictive hypertrophic scars through regular assessment of adverse events.
Measured: 12 weeks
Secondary outcomes (5)
Percentage of Subjects Worse Hypertrophic Scars
The secondary objectives of this study are to evaluate improvement in symptoms of hypertrophic scars.
Measured: Endpoints assessed at Day 84.
Vancouver Scar Scale
Vancouver scar scale will be evaluated for each cohort. The Vancouver scar scale is the most frequently cited assessment of scar severity used in clinical studies. Pigmentation, vascularity, pliability, and scar height are graded producing a composite score. A score of 0 represents normal skin with higher grades representing greater deformity with a maximum possible rating of 14.
Measured: 12 weeks
Patient and Observer Scar Assessment Scale (POSAS)
POSAS aims to measure scar quality, it is a comprehensive scale designed for the evaluation of all types of scars by professionals and patients. It contains two scales with six items, scored numerically from 0-10, where 0 is normal skin and 10 is the worst scar imaginable. the total scoring range is from 0-120.
Measured: 12 weeks
Disability Index-Disability of Arm, Shoulder and Hand
The six subjects suffering from upper extremity and cervical scar contractures were evaluated with the Disability of Arm, Shoulder and Hand (DASH) questionnaire. The DASH questionnaire evaluates symptoms and functional status. A lowest score of 0 indicates normal skin and highest score of 100 represents the greatest possible morbidity.
Measured: 12 weeks
Quality of Life Measurement - Satisfaction With Appearance Scale (SWAP)
SWAP is a psychological test for personality diagnosis. there are 9 questions evaluated by a score of 7 (most descriptive to the patient) to 0 (not descriptive or irrelevant) for a total scoring range of 0-63.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2012 (estimated)
- Study startJan 2011
- Primary completionFeb 2014
- Study completionFeb 2014
Why it stopped: Study Terminated due to lack of Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Restrictive Scar ContractureStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, J. Peter Rubin, MD, University of Pittsburgh
- Investigators
- J. Peter Rubin, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01564407
- Sponsor's protocol ID
- PRO10110342
- Status last verified
- Jun 2017
- First submitted
- 20 Dec 2011
- Last updated
- 11 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Clinical Study of Allogeneic Human Dermal Fibroblasts for Remodeling Scar Contractures
- ClinicalTrials.gov ID
- NCT01564407
- Acronym / sponsor ID
- PRO10110342
- 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
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study Terminated due to lack of Funding
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Jan 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 27 Mar 2012 (estimated)
- Results
- Posted 12 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Safety Cohort | Experimental | Drug: ICX-RHY-013Stable 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. |
| 2.5M cells/cm2 | Active comparator | Drug: ICX-RHY-013Participants receive intervention treatment of 2.5 million cells/ cm2, single administration injected into the scar. |
| 5M cells/cm2 | Active comparator | Drug: ICX-RHY-013Participants receive intervention treatment of 5 million cells /cm2, single administration |
| 2.5M cells/cm2 at 4 weeks | Active comparator | Drug: ICX-RHY-013Participants receive intervention treatment of 2.5 million cells/ cm2, repeat dose administration @ 4 weeks |
| 5M cells/cm2 at 4 weeks | Active comparator | Drug: ICX-RHY-013Participants receive intervention treatment of 5 million cells / cm2 repeat dose administration @ 4 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects who are male or female, military or civilian, age 18 to 65 years of age and able to provide informed consent
- Subjects who have suffered an injury which has occurred no less than 6 weeks prior to their screening date which has resulted in a stable restrictive scar contracture
- Subjects will have a minimum scar length of 7 cm and a maximum scar area size of 80cm² (Cohort 1 only)
- Subjects will have a minimum scar area size of 1cm² and a maximum scar area size of 80cm² (Cohort 2-5 only).
- Subjects who are, in the opinion of the Investigator, able to understand the study, comply with the study design and are willing to return to the clinic for all the research required follow-up visits
Key exclusion criteria (23 listed)
- Subjects with previous use of cellular therapy (e.g. Isolagen) in the treatment area
- Subjects with a known history of keloids
- Subjects with a known history of bleeding disorders
- Subjects who have facial restrictive scar deficits, not to exclude the neck area.
- Subjects who have had contracture-release procedures in the treatment area within the previous six months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICX-RHY-013Also: Allogeneic human dermal fibroblastsDrug 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 | Drug | 2.5M cells/cm2, 2.5M cells/cm2 at 4 weeks, 5M cells/cm2, 5M cells/cm2 at 4 weeks, Safety Cohort |
Primary outcome
Number of Participants With Adverse Events
Time frame: Days 0, 7, 14, 28, 56, 84
The evaluation of safety of ICX-RHY-013 in the treatment of stable, restrictive hypertrophic scars through assessment of adverse events. The primary objective of the safety (no injection) cohort is to evaluate initial safety of multiple doses through assessment of adverse events. The primary objective of remaining cohorts is to evaluate the ongoing safety of ICX-RHY-013 in post-burn hypertrophic scars that are not planned for excision through assessment of adverse events.
Number of Participants With Serious Adverse Events Reported
Time frame: 12 weeks
The evaluation of tolerability of ICX-RHY-013 in the treatment of stable, restrictive hypertrophic scars through regular assessment of adverse events.
5 secondary outcomes
Percentage of Subjects Worse Hypertrophic Scars
Time frame: Endpoints assessed at Day 84.
Vancouver Scar Scale
Time frame: 12 weeks
Patient and Observer Scar Assessment Scale (POSAS)
Time frame: 12 weeks
Disability Index-Disability of Arm, Shoulder and Hand
Time frame: 12 weeks
Quality of Life Measurement - Satisfaction With Appearance Scale (SWAP)
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J. Peter Rubin, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ICX-RHY-013 in people with Restrictive Scar Contracture and Restrictive Hypertrophic Scar, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (time frame: Days 0, 7, 14, 28, 56, 84). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2017.