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

NCT01564407 | Terminated Phase 1 Results DMC

• 1 other identifier: PRO10110342
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  12 weeks

Secondary Outcomes (5)

• Percentage of Subjects Worse Hypertrophic Scars

  Endpoints assessed at Day 84.

• Vancouver Scar Scale

  12 weeks

• Patient and Observer Scar Assessment Scale (POSAS)

  12 weeks

• Disability Index-Disability of Arm, Shoulder and Hand

  12 weeks

• Quality of Life Measurement - Satisfaction With Appearance Scale (SWAP)

  12 weeks

Study Arms (5)

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.

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.

Drug: ICX-RHY-013

5M cells/cm2

ACTIVE COMPARATOR

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

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

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

Drug: ICX-RHY-013

Interventions

ICX-RHY-013 DRUG

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

2.5M cells/cm2; 2.5M cells/cm2 at 4 weeks; 5M cells/cm2; 5M cells/cm2 at 4 weeks; Safety Cohort

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• United States Department of Defense: collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Amy Steele, RN, MSN, CCRC
• Organization: University of Pittsburgh

steeleam@upmc.edu

412-641-3728

Study Officials

• J. Peter Rubin, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: December 20, 2011
• First Posted: March 27, 2012
• Study Start: January 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: July 11, 2017
• Results First Posted: May 12, 2017

Record last verified: 2017-06

Locations

US (1)