Safety of Repaircell in Healthy Volunteers
This study has been completed.
Sponsor:
Anterogen Co., Ltd.
Information provided by (Responsible Party):
Anterogen Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01739530
First received: November 15, 2012
Last updated: December 3, 2012
Last verified: December 2012
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Purpose
Allogenic differentiated adipocytes (ANT-adip-AL) is produced by well-established techniques including cell harvesting from lipoaspirates obtained from healthy donors, expansion of adipose tissue derived stem cells, and differentiation into pure and immature adipocytes. This was an open-label study. Subjects were received subcutaneous injection of ANT-adip-AL and followed for 8 weeks according to the clinical trial protocol.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Biological: Repaircell |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Study to Evaluate Safety of Repaircell in Healthy Volunteers |
Further study details as provided by Anterogen Co., Ltd.:
Primary Outcome Measures:
- Number of Adverse events [ Time Frame: week 8 ] [ Designated as safety issue: Yes ]Evaluate the safety at week 8 whether any kind of Adverse event occurs
Secondary Outcome Measures:
- Immunological response II [ Time Frame: week 8 ] [ Designated as safety issue: Yes ]Infiltration of immune cells by histology based on five basic parameters: (0) No evidence of immune cell infiltration in all area of the tissue, (1) Slight immune cell infiltration visible in partial area of the tissue (barely visible), (2) Obvious immune cell infiltration visible in partial area of the tissue, (3) Slight immune cell infiltration visible in all area of the tissue, and (4) Intense immune cell infiltration visible in all areas of the tissue.
- Immunological response I [ Time Frame: change from baseline CD4/CD8 ratio at week 8 ] [ Designated as safety issue: Yes ]CD4 (cluster of differentiation 4)/CD8 (cluster of differentiation 8) ratio
| Enrollment: | 5 |
| Study Start Date: | March 2009 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Repaircell
allogenic differentiated adipocyte
|
Biological: Repaircell
allogenic differentiated adipocyte
Other Name: Repaircell
|
Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- male, 19 years of age or older
- volunteers in good health as confirmed by physical examination, medical history, and clinical laboratory tests of blood and urine at the time of screening
- informed consent form signed
Exclusion Criteria:
- volunteers who have participated in other clinical studies related cell therapy within 30 days before this clinical trial
- volunteers who received any immune-suppressive drug, corticosteroid or cytotoxic drug within the previous 30 days
- volunteers who have tattoo or scar which disturb assessment of study at injection site
- volunteers who have Creutzfeldt Jacobs disease or related disease or family history
- volunteers who have allergy to bovine-derived materials
- volunteers who have infectious disease such as hepatitis B virus (HBV), hepatitis C virus (HCV)and HIV
- volunteers who have a symptom of septicemia or diagnosis of active Tuberculosis
- volunteers who have a clinically relevant history of abuse of alcohol or drugs
- volunteers who are considered not suitable for the study by investigator
- volunteers who have history of surgery for malignant cancer in the past 5 years
- volunteers who have congenital or acquired immunodeficiency syndrome
- volunteers who have horrible anemia or thrombopenia
- volunteers who have chronic disease such cardiovascular,renal and respirometer disease
- volunteers who were immunosuppressed by disease (ex: chronic heart failure)
- volunteers who were immunodepressed by treatment of medication
- volunteers who is being treated with blood derivatives/who is going to get a blood derivatives
- volunteers who have abnormal rage of CD4/CD8 ratio
Contacts and Locations More Information
No publications provided
| Responsible Party: | Anterogen Co., Ltd. |
| ClinicalTrials.gov Identifier: | NCT01739530 History of Changes |
| Other Study ID Numbers: | ANT-adip-AL-001 |
| Study First Received: | November 15, 2012 |
| Last Updated: | December 3, 2012 |
| Health Authority: | Korea: Food and Drug Administration |
ClinicalTrials.gov processed this record on May 23, 2013