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TerminatedNCT01564407Updated Jul 11, 2017Results posted

A Clinical Study of Allogeneic Human Dermal Fibroblasts for Remodeling Scar Contractures

A Phase 1/2 interventional study of ICX-RHY-013 in Restrictive Scar Contracture, Restrictive Hypertrophic Scar and Burn Scar Contractures, sponsored by University of Pittsburgh. Terminated at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-11.

Sponsored by University of Pittsburgh · Phase 1/2, Interventional, and Basic science

Why this study was terminated
Study Terminated due to lack of Funding
Phase
Phase 1/2
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • 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
03

In context

Contracture

151 studies on the registry are indexed under Contracture; 21 are open to participants now.

This study's enrollment of 15 is below the median of 40 across 110 interventional studies indexed under Contracture.

Browse Contracture studies →

Lead sponsor

University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Subjects who are male or female, military or civilian, age 18 to 65 years of age and able to provide informed consent

  2. 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

    1. Stable restrictive scar contracture that has resulted from abdominal surgical incision and does not transverse a joint (Cohort 1 only).
    2. Stable restrictive scar contracture has resulted from a burn injury and may transverse a joint (Cohorts 2-5 only)
  3. Subjects will have a minimum scar length of 7 cm and a maximum scar area size of 80cm² (Cohort 1 only)
  4. Subjects will have a minimum scar area size of 1cm² and a maximum scar area size of 80cm² (Cohort 2-5 only).
  5. 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

Exclusion criteria

Exclusion Criteria:

  1. Subjects with previous use of cellular therapy (e.g. Isolagen) in the treatment area
  2. Subjects with a known history of keloids
  3. Subjects with a known history of bleeding disorders
  4. Subjects who have facial restrictive scar deficits, not to exclude the neck area.
  5. Subjects who have had contracture-release procedures in the treatment area within the previous six months
  6. Subjects with a known allergy to any of the constituents of HypoThermosol-FRS
  7. 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)
  8. Diagnosis of cancer within last 12 months and /or actively receiving chemotherapy or radiation treatment
  9. Subjects with a life expectancy of \<9 months, terminal conditions or factors making follow-up difficult (e.g. no fixed address, telephone etc)
  10. Subjects with a history of hypersensitivity to additional study-associated drugs/therapies (e.g. isopropyl alcohol, EMLA cream, adrenaline, lidocaine, etc)
  11. Subjects with planned major surgical intervention during the course of the study.
  12. Subjects with known idiopathic or drug-associated coagulopathy
  13. 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
  14. 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.
  15. 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
  16. 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).
  17. 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.
  18. Subjects with evidence of any past or present clinically significant medical condition that would impair wound healing
  19. Subjects with a known hypersensitivity to gentamycin, amphotericin B, Bovine serum or porcine products.
  20. Subjects with known alcohol or narcotic drug dependency
  21. Subjects with diagnosed autoimmune disorders known to affect wound healing, such as Systemic Lupus Erythematosis (SLE), psoriasis, infection and inflammation (seborrheic dermatitis).
  22. Subjects receiving an immunosuppressive medication regime including transplant anti-rejection agents.
  23. 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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    Safety Cohort

    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.

    Drug: ICX-RHY-013

  • Active comparator
    2.5M cells/cm2

    Participants receive intervention treatment of 2.5 million cells/ cm2, single administration injected into the scar.

    Drug: ICX-RHY-013

  • Active comparator
    5M cells/cm2

    Participants receive intervention treatment of 5 million cells /cm2, single administration

    Drug: ICX-RHY-013

  • Active comparator
    2.5M cells/cm2 at 4 weeks

    Participants receive intervention treatment of 2.5 million cells/ cm2, repeat dose administration @ 4 weeks

    Drug: ICX-RHY-013

  • Active comparator
    5M cells/cm2 at 4 weeks

    Participants receive intervention treatment of 5 million cells / cm2 repeat dose administration @ 4 weeks

    Drug: ICX-RHY-013

Interventions

  • DrugICX-RHY-013

    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

    Also known as: Allogeneic human dermal fibroblasts

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Days 0, 7, 14, 28, 56, 84

  2. 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.

    Time frame: 12 weeks

Secondary outcomes

  1. Percentage of Subjects Worse Hypertrophic Scars

    The secondary objectives of this study are to evaluate improvement in symptoms of hypertrophic scars.

    Time frame: Endpoints assessed at Day 84.

  2. 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.

    Time frame: 12 weeks

  3. 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.

    Time frame: 12 weeks

  4. 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.

    Time frame: 12 weeks

  5. 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.

    Time frame: 12 weeks

07

Results

Posted May 12, 2017

Participant flow

Multiple approaches for subject recruitment were implemented.The Center for Innovation in Restorative (CIRM) hired a marketing specialist who investigated the use of non-traditional mechanisms within and outside the existing infrastructure including but not limited to social media outlet,use of internal/external physician networks,TV advertising

Participant flow — Overall Study
MilestoneNo InjectionVehicle OnlySingle Admin Drug Day 0Single Admin Drug Day 28Admin Drug Day 0 and 28
Started45420
Completed43410
Not completed02010
Withdrew: Lost to follow-up01000
Withdrew: Withdrawal by subject01000
Withdrew: Funding lost, study ended00010

Outcome measures

PrimaryNumber 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.

Time frame:
Days 0, 7, 14, 28, 56, 84
Reported as:
Number · participants
Number of Participants With Adverse Events
participantsno InjectionVehicle OnlySingle Admin Drug Day 0Single Admin Drug Day 28
Number of Participants With Adverse Events4341
PrimaryNumber 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.

Time frame:
12 weeks
Reported as:
Number · participants
Number of Participants With Serious Adverse Events Reported
participantsNo InjectionVehicle OnlySingle Admin Drug Day 0Single Admin Drug Day 28
Number of Participants With Serious Adverse Events Reported0000
SecondaryPercentage of Subjects Worse Hypertrophic Scars

The secondary objectives of this study are to evaluate improvement in symptoms of hypertrophic scars.

Time frame:
Endpoints assessed at Day 84.
Reported as:
Number · percentage of paricipants
Percentage of Subjects Worse Hypertrophic Scars
percentage of paricipantsno InjectionVehicle OnlySingle Admin Drug Day 0Single Admin Drug Day 28
Percentage of Subjects Worse Hypertrophic Scars0000
SecondaryVancouver 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.

Time frame:
12 weeks
Reported as:
Mean · scores on a scale
Vancouver Scar Scale
scores on a scaleSingle Admin Day 0Single Admin Day 28Admin Day 0 and 28No InjectionVehicle Only
Vancouver Scar Scale8 ± 210 ± 2.2—10 ± 38 ± 1.3
SecondaryPatient 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.

Time frame:
12 weeks
Reported as:
Mean · scores on a scale
Patient and Observer Scar Assessment Scale (POSAS)
scores on a scaleSingle Admin Day 0Single Admin Day 28Admin Day 0 and 28No InjectionVehicle Only
Patient and Observer Scar Assessment Scale (POSAS)24.67 ± 1.5334.25 ± 11.32—42.13 ± 8.1641.57 ± 4.32
SecondaryDisability 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.

Time frame:
12 weeks
Reported as:
Mean · scores on a scale
Disability Index-Disability of Arm, Shoulder and Hand
scores on a scaleSingle Admin Day 0Single Admin Day 28Admin Day 0 and 28No InjectionVehicle Only
Disability Index-Disability of Arm, Shoulder and Hand6.9 ± 611.6 ± 14.1—75.5 ± 3.869.2 ± 12.7
SecondaryQuality 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.

Time frame:
12 weeks
Reported as:
Mean · units on a scale
Quality of Life Measurement - Satisfaction With Appearance Scale (SWAP)
units on a scaleSingle Admin Day 0Single Admin Day 28Admin Day 0 and 28No InjectionVehicle Only
Quality of Life Measurement - Satisfaction With Appearance Scale (SWAP)5.67 ± 7.3737.75 ± 14.73—13.35 ± 4.1223.27 ± 9.87

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Vehicle Only,0/5 (0%)0/5 (0%)5/5 (100%)
Single Admin Day 00/4 (0%)0/4 (0%)4/4 (100%)
Single Admin Day 280/2 (0%)0/2 (0%)2/2 (100%)
Admin Day 0 and 28———
no Injection0/4 (0%)0/4 (0%)0/4 (0%)
Most frequent other events
Most frequent other events
EventVehicle Only,Single Admin Day 0Single Admin Day 28Admin Day 0 and 28no Injection
ItchingSkin and subcutaneous tissue disorders3/53/42/2—0/4
RednessSkin and subcutaneous tissue disorders4/53/41/2—0/4
PainSkin and subcutaneous tissue disorders3/52/41/2—0/4
BruisingSkin and subcutaneous tissue disorders2/51/41/2—0/4
SwellingSkin and subcutaneous tissue disorders1/52/41/2—0/4
WarmthSkin and subcutaneous tissue disorders0/51/41/2—0/4
BleedingBlood and lymphatic system disorders1/51/40/2—0/4

Baseline characteristics

Age, Customized
Age, Customized(participants)No InjectionVehicle OnlySingle Admin Day 0Single Admin Day 28Admin Day 0 and 28Total
<=18 years0000—0
Between 18 and 65 years4542—15
>=65 years0000—0
Age, Continuous
Age, Continuous(years)No InjectionVehicle OnlySingle Admin Day 0Single Admin Day 28Admin Day 0 and 28Total
Mean32.25 ± 12.341.25 ± 17.045.75 ± 14.962 ± 0—45.3 ± 12.4
Sex/Gender, Customized
Sex/Gender, Customized(participants)No InjectionVehicle OnlySingle Admin Day 0Single Admin Day 28Admin Day 0 and 28Total
Female4100—5
Male0442—10
Region of Enrollment
Region of Enrollment(participants)No InjectionVehicle OnlySingle Admin Day 0Single Admin Day 28Admin Day 0 and 28Total
United States4542—15
08

Study locations

1 site
  • University of Pittsburgh
    Pittsburgh, Pennsylvania 15213, United States
09

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01564407
Lead sponsor
University of Pittsburgh
Collaborators
United States Department of Defense
Responsible party
J. Peter Rubin, MD (Prinicipal Investigator, University of Pittsburgh) — Principal investigator
First posted
Mar 27, 2012
Start date
Jan 2011
Primary completion
Feb 2014
Completion
Feb 2014
Results posted
May 12, 2017
Last update
Jul 11, 2017

Study contacts

J. Peter Rubin, MD
principal investigator · University of Pittsburgh

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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