Study of Survival Duration for Donor Skin Cells in Skin Biopsy Wounds
This study has been completed.
Sponsor:
Healthpoint
Information provided by (Responsible Party):
Healthpoint
ClinicalTrials.gov Identifier:
NCT01190865
First received: August 26, 2010
Last updated: December 1, 2011
Last verified: December 2010
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | August 26, 2010 | ||||||||
| Last Updated Date | December 1, 2011 | ||||||||
| Start Date ICMJE | September 2010 | ||||||||
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Presence of Y Chromosome Genetic Markers [ Time Frame: 57 Days ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01190865 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Identification of Donor Cell Type [ Time Frame: 57 Days ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Study of Survival Duration for Donor Skin Cells in Skin Biopsy Wounds | ||||||||
| Official Title ICMJE | A Phase I Study Investigating the Survival of HP802-247 Allogeneic Cells in Excisional Acute Cutaneous Wounds | ||||||||
| Brief 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. |
||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 1 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
||||||||
| Condition ICMJE | Normal Female Volunteers | ||||||||
| Intervention ICMJE | 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. |
||||||||
| Study Arm (s) | 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
Intervention: Biological: HP802-247 |
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 28 | ||||||||
| Completion Date | December 2010 | ||||||||
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Female | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01190865 | ||||||||
| Other Study ID Numbers ICMJE | 802-247-09-021 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Healthpoint | ||||||||
| Study Sponsor ICMJE | Healthpoint | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | Healthpoint | ||||||||
| Verification Date | December 2010 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||