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The purpose of this study is to evaluate the safety profile and the treatment effect of Isolagen TherapyTM in subjects with maxillary lesions who were treated in a previous study (IT-G-002, no NCT identification number)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Human Fibroblasts (azficel-T) | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Responders Based on the Average Investigator Evaluation of Change From Baseline for All Treated Areas on the Global Ordinal Rating Scale (GORS) | A patient was considered a responder in this outcome measure if the average Investigator's GORS score for all treatment areas was greater than 0. On the GORS, a score of -2 (much worsening from baseline) was the worst and +2 (great improvement from baseline) was the best. | Baseline (prior to first study treatment) compared to six months after first treatment |
| Number of Responders Based on the Average Patient Evaluation of Change From Baseline for All Treated Areas on the Global Ordinal Rating Scale (GORS) | A patient was considered a responder in this outcome measure if the average patient's GORS score for all treatment areas was greater than 0. On the GORS, a score of -2 (much worsening from baseline) was the worst and +2 (great improvement from baseline) was the best. | Baseline (prior to first study treatment) compared to six months after first treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Perio-Health Professionals, Inc. | Houston | Texas | 77063 | United States |
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Patients were recruited between July 17, 2006 to September 11, 2006.
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| ID | Title | Description |
|---|---|---|
| FG000 | Autologous Fibroblasts | Patients received autologous fibroblasts to maxillary interdental papillary recessions that were treated with fibroblasts or placebo in a previous study. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Autologous Fibroblasts | Patients received autologous fibroblasts to maxillary interdental papillary recessions that were treated with fibroblasts or placebo in a previous study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Responders Based on the Average Investigator Evaluation of Change From Baseline for All Treated Areas on the Global Ordinal Rating Scale (GORS) | A patient was considered a responder in this outcome measure if the average Investigator's GORS score for all treatment areas was greater than 0. On the GORS, a score of -2 (much worsening from baseline) was the worst and +2 (great improvement from baseline) was the best. | Subjects who received at least one treatment during the study were included in the Intent to Treat population | Posted | Number | participants | Baseline (prior to first study treatment) compared to six months after first treatment |
|
Adverse event data were collected for one year after first study treatment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Autologous Fibroblasts | Patients received autologous fibroblasts to maxillary interdental papillary recessions that were treated with fibroblasts or placebo in a previous study (IT-G-002, no NCT identification number). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Gastrointestinal disorders | COSTART | Non-systematic Assessment | Patient experienced an event of appendicitis. The event was considered unrelated to study treatment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Accidental Injury | General disorders | COSTART | Non-systematic Assessment |
This was a small, open-label study without a placebo control, and was not powered to provide statistically significant demonstrations of product efficacy.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Joseph Fratantoni | Biologics Consulting Group | (301) 340-8432 | jfratantoni@bcg-usa.com |
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|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Primary | Number of Responders Based on the Average Patient Evaluation of Change From Baseline for All Treated Areas on the Global Ordinal Rating Scale (GORS) | A patient was considered a responder in this outcome measure if the average patient's GORS score for all treatment areas was greater than 0. On the GORS, a score of -2 (much worsening from baseline) was the worst and +2 (great improvement from baseline) was the best. | Subjects who received at least one treatment during the study were included in the Intent to Treat population | Posted | Number | participants | Baseline (prior to first study treatment) compared to six months after first treatment |
|
|
|
| 1 |
| 13 |
| 7 |
| 13 |
|
| Herpes Simplex | Skin and subcutaneous tissue disorders | COSTART | Non-systematic Assessment |
|
| Gastroenteritis | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
|
| Rosacea | Skin and subcutaneous tissue disorders | COSTART | Non-systematic Assessment |
|
| Periodontal Abscess | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
|
| Flu Syndrome | General disorders | COSTART | Non-systematic Assessment |
|
| Upper Respiratory Infection | Respiratory, thoracic and mediastinal disorders | COSTART | Non-systematic Assessment |
|
| Muscle Spasm | Musculoskeletal and connective tissue disorders | COSTART | Non-systematic Assessment |
|
| Sinusitis | Respiratory, thoracic and mediastinal disorders | COSTART | Non-systematic Assessment |
|
Publications or presentations by the Investigator or his associates, were required to be submitted to the sponsor for review and approval prior to publication or presentation in any form.