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Study of Survival Duration for Donor Skin Cells in Skin Biopsy Wounds

NCT01190865 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2017-07-02

Study results available
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Summary

The goal for this study is to examine the persistence of growth arrested,allogeneic,male-donor keratinocytes and fibroblasts when applied as product HP802-247 to the surface of acute excisional wounds in health female volunteers, as measured using Y-STR for detection of Y-chromosome.

Conditions

  • Normal Female Volunteers

Interventions

BIOLOGICAL

HP802-247

One dose of HP802-247 consisting off 260 mL containing keratinocytes and fibroblasts totaling 5.0 x 10.6 cells per mL, plus fibrin.

Sponsors & Collaborators

  • Healthpoint

    lead INDUSTRY

Principal Investigators

  • Herbert B Slade, MD · Healthpoint, Ltd

  • Barry Reece, MS · RCTS, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2010-12-31
Completion
2010-12-31

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 NCT01190865 on ClinicalTrials.gov