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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Pittsburgh
Sponsor:
Collaborator:
Information provided by (Responsible Party):
J. Peter Rubin, MD, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01564407
First received: December 20, 2011
Last updated: March 19, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Restrictive Scar Contracture
Restrictive Hypertrophic Scar
Burn Scar Contractures
Burn Scar
Drug: ICX‐RHY‐013
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Phase I/II Clinical Study of Allogeneic Human Dermal Fibroblasts for Remodeling Scar Contractures

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • The primary objective of this study is to evaluate the safety and tolerability of ICX-RHY-013 [ Time Frame: Efficacy endpoints assessed at Days 0, (baseline) and 7, 14, 28, 56, 84. ] [ Designated as safety issue: Yes ]
    The evaluation of safety and tolerability of ICX-RHY-013 in the treatment of stable, restrictive hypertrophic scars through regular assessment of adverse events, vital signs, laboratory assessments and histology. The primary objective of cohort 1 is to evaluate initial safety of multiple doses, including maximum proposed dose on scars to be excised. The primary objective of cohorts 2-5 is to evaluate the ongoing safety of ICX-RHY-013 in post-burn hypertrophic scars that are not planned for excision using a dose escalation scheme, which will not exceed the maximum dose used in cohort 1.


Secondary Outcome Measures:
  • Evaluation of improvement in symptoms of hypertrophic scars. [ Time Frame: Endpoints assessed at Day 84. ] [ Designated as safety issue: No ]
    The secondary objectives of this study are to evaluate improvement in symptoms of hypertrophic scars including reduced pain, reduced discomfort and itching, improvement in mobility and daily function, improvement in cosmetic appearance and scar texture; to assess subject and investigator satisfaction with scar appearance and to determine the fate of injected cells. We will also assess cellular properties of the biopsy tissue material obtained from each subject for future correlation of the clinical outcomes.


Estimated Enrollment: 20
Study Start Date: January 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Safety Cohort 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.
Drug: ICX‐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

Other Name: Allogeneic human dermal fibroblasts
Active Comparator: Cohort 2
Stable restrictive scar contracture has resulted from a burn injury and may transverse a joint with a minimum scar area size of 1cm² and a maximum scar area size of 80cm². Dose: 2.5 million cells/ cm2, single administration injected into the scar.
Drug: ICX‐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

Other Name: Allogeneic human dermal fibroblasts
Active Comparator: Cohort 3
Stable restrictive scar contracture has resulted from a burn injury and may transverse a joint with a minimum scar area size of 1cm² and a maximum scar area size of 80cm². Dose: 5 million cells /cm2, single administration
Drug: ICX‐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

Other Name: Allogeneic human dermal fibroblasts
Active Comparator: Cohort 4
Stable restrictive scar contracture has resulted from a burn injury and may transverse a joint with a minimum scar area size of 1cm² and a maximum scar area size of 80cm². Dose: 2.5 million cells/ cm2, repeat dose administration @ 4 weeks
Drug: ICX‐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

Other Name: Allogeneic human dermal fibroblasts
Active Comparator: Cohort 5
Stable restrictive scar contracture has resulted from a burn injury and may transverse a joint with a minimum scar area size of 1cm² and a maximum scar area size of 80cm². Dose: 5 million cells / cm2 repeat dose administration @ 4 weeks
Drug: ICX‐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

Other Name: Allogeneic human dermal fibroblasts

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01564407

Contacts
Contact: Mara A Yerk 412-864-2588 yerkma@upmc.edu
Contact: Patsy Simon, RN, BS 412-864-2580 simonpa@upmc.edu

Locations
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Nancy E McCormick, MS    412-864-2583    mccormickne@upmc.edu   
Contact: Patsy Simon, RN, BS    412-864-2580    simonpa@upmc.edu   
Principal Investigator: J. Peter Rubin, MD         
Sub-Investigator: Fabrisia Ambrosio, MPT         
Sub-Investigator: Michael Boninger, MD         
Sub-Investigator: Carlynn Jackson, BS, CCRC         
Sub-Investigator: Nancy McCormick, MS, CCRC         
Sub-Investigator: Vu Nguyen, MD         
Sub-Investigator: Patsy Simon, RN, BS, CCRC         
Sub-Investigator: Spencer Brown, PhD         
Sub-Investigator: Paul Afrooz, MD         
Sub-Investigator: Wendy Wakefield, CRNP         
Sub-Investigator: Jenelle Mock, RN, BSN         
Sub-Investigator: Peter Adams, BS         
Sub-Investigator: Jacqueline Bliley, MS         
Sub-Investigator: Jeffrey Gusenoff, MD         
Sub-Investigator: Louise Martin, RN, BSN, CCRC         
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: J. Peter Rubin, MD University of Pittsburgh
  More Information

No publications provided

Responsible Party: J. Peter Rubin, MD, Prinicipal Investigator, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01564407     History of Changes
Other Study ID Numbers: PRO10110342
Study First Received: December 20, 2011
Last Updated: March 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pittsburgh:
ICX‐RHY‐013
Restrictive scar contracture
Restrictive hypertrophic scar
Burn Scar
Burn Scar contractures
Scar

Additional relevant MeSH terms:
Cicatrix
Cicatrix, Hypertrophic
Burns
Contracture
Hypertrophy
Fibrosis
Joint Diseases
Muscular Diseases
Musculoskeletal Diseases
Pathologic Processes
Pathological Conditions, Anatomical
Wounds and Injuries

ClinicalTrials.gov processed this record on October 21, 2014