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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Healthpoint
ClinicalTrials.gov Identifier:
NCT01190865
First received: August 26, 2010
Last updated: September 13, 2016
Last verified: September 2016
Results First Received: September 13, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Normal Female Volunteers
Intervention: Biological: HP802-247

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were enrolled at a single US investigational site, between September 14, 2010 and December 08, 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
subjects underwent buccal smear to ensure absence of a Y chromosome or translocated material from a Y chromosome. Day 1, all subjects underwent a baseline 3mm skin punch biopsy on the inner upper arm followed by a single application of HP802-247.

Reporting Groups
  Description
HP802-247

Assessment Duration = 8 days Assessment Duration = 15 days Assessment Duration = 22 days Assessment Duration = 29 days Assessment Duration = 31 days Assessment Duration = 43 days Assessment Duration = 50 days Assessment Duration = 57 days

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.


Participant Flow:   Overall Study
    HP802-247
STARTED   28 
COMPLETED   25 
NOT COMPLETED   3 
Withdrawal by Subject                1 
Non-compliance                2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
HP802-247

Assessment Duration = 8 days Assessment Duration = 15 days Assessment Duration = 22 days Assessment Duration = 29 days Assessment Duration = 31 days Assessment Duration = 43 days Assessment Duration = 50 days Assessment Duration = 57 days

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.


Baseline Measures
   HP802-247 
Overall Participants Analyzed 
[Units: Participants]
 28 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   27 
>=65 years   1 
Gender 
[Units: Participants]
 
Female   28 
Male   0 
Ethnicity (NIH/OMB) 
[Units: Participants]
 
Hispanic or Latino   3 
Not Hispanic or Latino   25 
Unknown or Not Reported   0 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   0 
Asian   0 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   5 
White   23 
More than one race   0 
Unknown or Not Reported   0 


  Outcome Measures
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1.  Primary:   The Percentage of Participants With Persistence of the Y Chromosome in Growth Arrested, Allogeneic, Male-donor Keratinocytes and Fibroblasts When Applied to the Surface of Acute Excisional Wounds in Healthy Female Volunteers   [ Time Frame: Cohorts of 3 subjects were biopsied at weekly intervals for 8 weeks ]

2.  Secondary:   Determination of the Time in Days to 50% Correct Identification (ID50) of the Implanted Male DNA 17 Loci in Female Volunteers, With Regard to Three DNA Profile Types, Including Partial DNA Profile, > 50% DNA Profile, and Full (or Complete) DNA Profile.   [ Time Frame: Cohorts of 3 subjects were biopsied at weekly intervals for 8 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Jaime E Dickerson, PhD
Organization: Smith & Nephew
phone: 1-817-302-3914
e-mail: Jaime.Dickerson@smith-nephew.com



Responsible Party: Healthpoint
ClinicalTrials.gov Identifier: NCT01190865     History of Changes
Other Study ID Numbers: 802-247-09-021
Study First Received: August 26, 2010
Results First Received: September 13, 2016
Last Updated: September 13, 2016