Trial Outcomes & Findings for Safety and Efficacy Study of Isolagen TherapyTM in the Treatment of Nasolabial Fold Wrinkles (NCT NCT00649428)

Last Updated: 2012-03-13

Results Overview

A two point improvement on the Subject's live assessment of the wrinkles of the lower part of the face as compared to baseline on the Subject Wrinkle Assessment was considered a responder. The Subject Wrinkle Assessment scale was a five point scale with a score of -2 (Very Dissatisfied) being the worst and a score of +2 (Very Satisfied) being the best.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

203 participants

Primary outcome timeframe

Baseline (prior to first treatment) and 6 months post final treatment

Results posted on

2012-03-13

Participant Flow

Patients were recruited between October 23, 2006 and February 9, 2007.

Patients were enrolled and biopsied for manufacture of study product. All randomized patients were included in the Intent to Treat (ITT) population.

Participant milestones

Participant milestones
Measure	Autologous Fibroblasts Patients treated with autologous dermal fibroblasts	Placebo Patients treated with placebo solution
Overall Study STARTED	100	103
Overall Study COMPLETED	80	88
Overall Study NOT COMPLETED	20	15

Reasons for withdrawal

Reasons for withdrawal
Measure	Autologous Fibroblasts Patients treated with autologous dermal fibroblasts	Placebo Patients treated with placebo solution
Overall Study Adverse Event	2	2
Overall Study Withdrawal by Subject	6	6
Overall Study Lost to Follow-up	1	3
Overall Study Insufficient manufacturing yield	5	1
Overall Study Protocol Violation	6	2
Overall Study Physician Decision	0	1

Baseline Characteristics

Safety and Efficacy Study of Isolagen TherapyTM in the Treatment of Nasolabial Fold Wrinkles

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Autologous Fibroblasts n=100 Participants Patients treated with autologous dermal fibroblasts	Placebo n=103 Participants Patients treated with placebo solution	Total n=203 Participants Total of all reporting groups
Ethnicity (NIH/OMB) Not Hispanic or Latino	90 Participants n=5 Participants	96 Participants n=7 Participants	186 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	57.5 years STANDARD_DEVIATION 8.32 • n=5 Participants	55.9 years STANDARD_DEVIATION 7.87 • n=7 Participants	56.7 years STANDARD_DEVIATION 8.12 • n=5 Participants
Sex: Female, Male Female	88 Participants n=5 Participants	94 Participants n=7 Participants	182 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	9 Participants n=7 Participants	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	94 Participants n=5 Participants	99 Participants n=7 Participants	193 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	100 participants n=5 Participants	103 participants n=7 Participants	203 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (prior to first treatment) and 6 months post final treatment

Population: Analysis population was the ITT population, defined as all randomized subjects.

Outcome measures

Outcome measures
Measure	Autologous Fibroblast n=100 Participants Patients treated with autologous fibroblasts (azficel-T).	Placebo n=103 Participants Patients treated with placebo solution.
Subject Wrinkle Assessment Responders	57 participants	31 participants

PRIMARY outcome

Timeframe: Baseline (prior to first treatment) and 6 months after last treatment

Population: Analysis population was the ITT population, defined as all randomized subjects.

A responder was defined as a two point improvement on the blinded Evaluator's live assessment of each of the bilateral nasolabial fold wrinkles at rest using the 6-point ordinal Lemperle Wrinkle Severity Scale. On the Lemperle scale, a score of 5 (Very Deep Wrinkle) is worst and a score of 0 (No Visible Wrinkle) is best.

Outcome measures

Outcome measures
Measure	Autologous Fibroblast n=100 Participants Patients treated with autologous fibroblasts (azficel-T).	Placebo n=103 Participants Patients treated with placebo solution.
Evaluator Wrinkle Severity Assessment Responders	33 participants	7 participants

SECONDARY outcome

Timeframe: Baseline (prior to first treatment) compared to 3rd treatment visit, 2 and 4 months post final treatment

Population: Analysis population was the ITT population, defined as all randomized subjects.

Outcome measures

Outcome measures
Measure	Autologous Fibroblast n=100 Participants Patients treated with autologous fibroblasts (azficel-T).	Placebo n=103 Participants Patients treated with placebo solution.
Subject Wrinkle Assessment Responders Responders at 3rd Treatment	38 participants	23 participants
Subject Wrinkle Assessment Responders Responders - 2 months Post Final Treatment	49 participants	25 participants
Subject Wrinkle Assessment Responders Responders - 4 months Post Final Treatment	48 participants	26 participants

SECONDARY outcome

Timeframe: Baseline (prior to first treatment) compared to 3rd treatment visit, 2 and 4 months post final treatment

Population: Analysis population was the ITT population, defined as all randomized subjects.

Outcome measures

Outcome measures
Measure	Autologous Fibroblast n=100 Participants Patients treated with autologous fibroblasts (azficel-T).	Placebo n=103 Participants Patients treated with placebo solution.
Evaluator Wrinkle Severity Assessment Responders Responders at 3rd Treatment	14 participants	5 participants
Evaluator Wrinkle Severity Assessment Responders Responders - 2 months Post Final Treatment	28 participants	10 participants
Evaluator Wrinkle Severity Assessment Responders Responders - 4 months Post Final Treatment	27 participants	9 participants

Adverse Events

Autologous Fibroblasts

Serious events: 2 serious events

Other events: 32 other events

Deaths: 0 deaths

Placebo

Serious events: 4 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Autologous Fibroblasts n=100 participants at risk Patients treated with autologous fibroblasts (azficel-T).	Placebo n=103 participants at risk Patients treated with placebo solution.
Cardiac disorders Myocardial Infarction	0.00% 0/100 • Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.	0.97% 1/103 • Number of events 1 • Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.
Gastrointestinal disorders Abdominal Pain	1.0% 1/100 • Number of events 1 • Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.	0.00% 0/103 • Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcimona	1.0% 1/100 • Number of events 1 • Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.	0.00% 0/103 • Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.
Musculoskeletal and connective tissue disorders Athralgia	1.0% 1/100 • Number of events 1 • Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.	0.00% 0/103 • Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer	0.00% 0/100 • Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.	0.97% 1/103 • Number of events 1 • Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.
Surgical and medical procedures Knee Arthroplasty	0.00% 0/100 • Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.	0.97% 1/103 • Number of events 1 • Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.
Psychiatric disorders Anxiety	0.00% 0/100 • Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.	0.97% 1/103 • Number of events 1 • Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.
Social circumstances Chemical Abuser	0.00% 0/100 • Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.	0.97% 1/103 • Number of events 1 • Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.

Other adverse events

Other adverse events
Measure	Autologous Fibroblasts n=100 participants at risk Patients treated with autologous fibroblasts (azficel-T).	Placebo n=103 participants at risk Patients treated with placebo solution.
General disorders Injection Site Bruising	4.0% 4/100 • Number of events 5 • Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.	11.7% 12/103 • Number of events 17 • Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.
General disorders Injection Site Erythema	23.0% 23/100 • Number of events 53 • Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.	16.5% 17/103 • Number of events 28 • Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.
General disorders Injection Site Pain	5.0% 5/100 • Number of events 6 • Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.	3.9% 4/103 • Number of events 5 • Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.
General disorders Injection Site Swelling	18.0% 18/100 • Number of events 41 • Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.	14.6% 15/103 • Number of events 27 • Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.
Infections and infestations Nasopharyngitis	6.0% 6/100 • Number of events 6 • Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.	2.9% 3/103 • Number of events 3 • Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.
Nervous system disorders Headache	1.0% 1/100 • Number of events 1 • Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.	4.9% 5/103 • Number of events 6 • Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.

Additional Information

Kevin Hennegan

CBR International Corp.

Phone: 720-746-1190

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.
Publication restrictions are in place

Restriction type: OTHER