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

NCT01564407 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2017-07-11

Study results available
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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

Interventions

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

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • J. Peter Rubin, MD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01564407 on ClinicalTrials.gov