Trial Outcomes & Findings for Safety and Efficacy Study of Isolagen TherapyTM in Treatment of Interdental Papillary Insufficiency (NCT NCT00655889)

Last Updated: 2021-03-23

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

13 participants

Primary outcome timeframe

Baseline (prior to first study treatment) compared to six months after first treatment

Results posted on

2021-03-23

Participant Flow

Patients were recruited between July 17, 2006 to September 11, 2006.

Participant milestones

Participant milestones
Measure	Autologous Fibroblasts Patients received autologous fibroblasts to maxillary interdental papillary recessions that were treated with fibroblasts or placebo in a previous study.
Overall Study STARTED	13
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Autologous Fibroblasts Patients received autologous fibroblasts to maxillary interdental papillary recessions that were treated with fibroblasts or placebo in a previous study.
Overall Study Inadequate cell growth	1
Overall Study Protocol Violation	1

Baseline Characteristics

Safety and Efficacy Study of Isolagen TherapyTM in Treatment of Interdental Papillary Insufficiency

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Autologous Fibroblasts n=13 Participants Patients received autologous fibroblasts to maxillary interdental papillary recessions that were treated with fibroblasts or placebo in a previous study.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=99 Participants
Age, Categorical >=65 years	1 Participants n=99 Participants
Sex: Female, Male Female	10 Participants n=99 Participants
Sex: Female, Male Male	3 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	13 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants

PRIMARY outcome

Timeframe: Baseline (prior to first study treatment) compared to six months after first treatment

Population: Subjects who received at least one treatment during the study were included in the Intent to Treat population

Outcome measures

Outcome measures
Measure	Autologous Fibroblasts n=12 Participants Patients received autologous fibroblasts to maxillary interdental papillary recessions that were treated with fibroblasts or placebo in a previous study.
Number of Responders Based on the Average Investigator Evaluation of Change From Baseline for All Treated Areas on the Global Ordinal Rating Scale (GORS)	10 participants

PRIMARY outcome

Timeframe: Baseline (prior to first study treatment) compared to six months after first treatment

Population: Subjects who received at least one treatment during the study were included in the Intent to Treat population

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.

Outcome measures

Outcome measures
Measure	Autologous Fibroblasts n=12 Participants Patients received autologous fibroblasts to maxillary interdental papillary recessions that were treated with fibroblasts or placebo in a previous study.
Number of Responders Based on the Average Patient Evaluation of Change From Baseline for All Treated Areas on the Global Ordinal Rating Scale (GORS)	9 participants

Adverse Events

Autologous Fibroblasts

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Autologous Fibroblasts n=13 participants at risk 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).
Gastrointestinal disorders Appendicitis	7.7% 1/13 • Number of events 1 • Adverse event data were collected for one year after first study treatment

Other adverse events

Other adverse events
Measure	Autologous Fibroblasts n=13 participants at risk 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).
General disorders Accidental Injury	7.7% 1/13 • Number of events 1 • Adverse event data were collected for one year after first study treatment
Skin and subcutaneous tissue disorders Herpes Simplex	7.7% 1/13 • Number of events 1 • Adverse event data were collected for one year after first study treatment
Gastrointestinal disorders Gastroenteritis	7.7% 1/13 • Number of events 1 • Adverse event data were collected for one year after first study treatment
Skin and subcutaneous tissue disorders Rosacea	7.7% 1/13 • Number of events 1 • Adverse event data were collected for one year after first study treatment
Gastrointestinal disorders Periodontal Abscess	7.7% 1/13 • Number of events 1 • Adverse event data were collected for one year after first study treatment
General disorders Flu Syndrome	7.7% 1/13 • Number of events 1 • Adverse event data were collected for one year after first study treatment
Respiratory, thoracic and mediastinal disorders Upper Respiratory Infection	7.7% 1/13 • Number of events 1 • Adverse event data were collected for one year after first study treatment
Musculoskeletal and connective tissue disorders Muscle Spasm	7.7% 1/13 • Number of events 1 • Adverse event data were collected for one year after first study treatment
Respiratory, thoracic and mediastinal disorders Sinusitis	7.7% 1/13 • Number of events 1 • Adverse event data were collected for one year after first study treatment

Additional Information

Dr. Joseph Fratantoni

Biologics Consulting Group

Phone: (301) 340-8432

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER