A Study to Evaluate and Compare Injections of Autologous Mixed Population of Dermal Cells Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0006931)
This study is ongoing, but not recruiting participants.
Sponsor:
Aderans Research Institute
Information provided by (Responsible Party):
Aderans Research Institute
ClinicalTrials.gov Identifier:
NCT01669746
First received: August 17, 2012
Last updated: December 6, 2012
Last verified: December 2012
| Tracking Information | |
|---|---|
| First Received Date ICMJE | August 17, 2012 |
| Last Updated Date | December 6, 2012 |
| Start Date ICMJE | June 2012 |
| Estimated Primary Completion Date | April 2013 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT01669746 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | Not Provided |
| Original Secondary Outcome Measures ICMJE | Not Provided |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | A Study to Evaluate and Compare Injections of Autologous Mixed Population of Dermal Cells Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0006931) |
| Official Title ICMJE | A Multi-center, Phase 2 Study of Ji Gami(TM) CN That Evaluates the Efficacy and Safety of ex Vivo-cultured, Expanded, Occipital Autologous Dermal and Epidermal Cells, Injected Into the Hair Loss Area of the Scalp of Male and Female Subjects With Alopecia |
| Brief Summary | Evaluate the ability of injections of Ji Gami(TM) CN to induce hair growth in male and female subjects with hair loss. |
| Detailed Description | Not Provided |
| Study Type ICMJE | Interventional |
| Study Phase | Phase 2 |
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Condition ICMJE |
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| Intervention ICMJE | Biological: Autologous cultured mixed population of dermal cells
A piece of occipital scalp is taken from the subject. A mixed population of dermal cells from this tissue are expanded in culture. The cells are then harvested. These cells are then injected into the balding area of the scalp of the original subject. |
| Study Arm (s) | Experimental: Treatment
Intervention: Biological: Autologous cultured mixed population of dermal cells |
| Publications * | Not Provided |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Active, not recruiting |
| Estimated Enrollment ICMJE | 40 |
| Completion Date | Not Provided |
| Estimated Primary Completion Date | April 2013 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both |
| Ages | 18 Years to 50 Years |
| 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 | NCT01669746 |
| Other Study ID Numbers ICMJE | CA-0006931 |
| Has Data Monitoring Committee | No |
| Responsible Party | Aderans Research Institute |
| Study Sponsor ICMJE | Aderans Research Institute |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | Aderans Research Institute |
| Verification Date | December 2012 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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