Trial Outcomes & Findings for Safety and Efficacy Study of Isolagen Therapy in the Treatment of Nasolabial Fold Wrinkles (NCT NCT00655356)

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

218 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 1 November 2006 to 27 January 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	110	108
Overall Study COMPLETED	93	98
Overall Study NOT COMPLETED	17	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Autologous Fibroblasts Patients treated with autologous dermal fibroblasts	Placebo Patients treated with placebo solution
Overall Study Withdrawal by Subject	3	4
Overall Study Sponsor Request	10	4
Overall Study Adverse Event	1	1
Overall Study Protocol Violation	2	1
Overall Study Other Reason	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Autologous Fibroblasts n=110 Participants Patients treated with autologous dermal fibroblasts	Placebo n=108 Participants Patients treated with placebo solution	Total n=218 Participants Total of all reporting groups
Age Continuous	53.9 years STANDARD_DEVIATION 10.38 • n=5 Participants	55.4 years STANDARD_DEVIATION 9.42 • n=7 Participants	54.6 years STANDARD_DEVIATION 9.92 • n=5 Participants
Sex: Female, Male Female	103 Participants n=5 Participants	95 Participants n=7 Participants	198 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	13 Participants n=7 Participants	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	98 Participants n=5 Participants	96 Participants n=7 Participants	194 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
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	98 Participants n=5 Participants	95 Participants n=7 Participants	193 Participants n=5 Participants
Race (NIH/OMB) More than one race	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	110 participants n=5 Participants	108 participants n=7 Participants	218 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 Fibroblasts n=110 Participants Patients treated with autologous fibroblasts (azficel-T).	Placebo n=108 Participants Patients treated with placebo solution.
Subject Wrinkle Assessment Responders	50 participants	19 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 Fibroblasts n=110 Participants Patients treated with autologous fibroblasts (azficel-T).	Placebo n=108 Participants Patients treated with placebo solution.
Evaluator Wrinkle Severity Assessment Responders	21 participants	8 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 Fibroblasts n=110 Participants Patients treated with autologous fibroblasts (azficel-T).	Placebo n=108 Participants Patients treated with placebo solution.
Subject Wrinkle Assessment Responders Visit 3	34 participants	20 participants
Subject Wrinkle Assessment Responders Visit 4	51 participants	25 participants
Subject Wrinkle Assessment Responders Visit 5	47 participants	24 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 Fibroblasts n=110 Participants Patients treated with autologous fibroblasts (azficel-T).	Placebo n=108 Participants Patients treated with placebo solution.
Evaluator Wrinkle Severity Assessment Responders Visit 3	17 participants	4 participants
Evaluator Wrinkle Severity Assessment Responders Visit 4	22 participants	8 participants
Evaluator Wrinkle Severity Assessment Responders Visit 5	26 participants	7 participants

Adverse Events

Autologous Fibroblasts

Serious events: 8 serious events

Other events: 32 other events

Deaths: 0 deaths

Placebo

Serious events: 7 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Autologous Fibroblasts n=98 participants at risk Patients treated with autologous fibroblasts (azficel-T).	Placebo n=99 participants at risk Patients treated with placebo solution.
General disorders Injection site bruising	5.1% 5/98 • Number of events 6 • Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.	13.1% 13/99 • Number of events 20 • Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.
General disorders Injection site erythema	14.3% 14/98 • Number of events 19 • Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.	6.1% 6/99 • Number of events 9 • Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.
General disorders Injection site haemorrhage	10.2% 10/98 • Number of events 30 • Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.	15.2% 15/99 • Number of events 45 • Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.
Infections and infestations Upper respiratory tract infection	8.2% 8/98 • Number of events 8 • Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.	6.1% 6/99 • 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

Measure	Autologous Fibroblasts n=98 participants at risk Patients treated with autologous fibroblasts (azficel-T).	Placebo n=99 participants at risk Patients treated with placebo solution.
Musculoskeletal and connective tissue disorders Spinal Column Stenosis	1.0% 1/98 • 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% 0/99 • Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.
Reproductive system and breast disorders Menorrhagia	0.00% 0/98 • Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.	2.0% 2/99 • Number of events 2 • Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.
Eye disorders Retinal Detachment	0.00% 0/98 • Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.	1.0% 1/99 • Number of events 2 • Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.
Infections and infestations Staphylococcal Infection	1.0% 1/98 • 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% 0/99 • Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.
Reproductive system and breast disorders Dysmenorrhoea	1.0% 1/98 • Number of events 2 • Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.	0.00% 0/99 • Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.
Reproductive system and breast disorders Endometriosis	1.0% 1/98 • 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% 0/99 • Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.
Musculoskeletal and connective tissue disorders Muscular Weakness	1.0% 1/98 • 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% 0/99 • Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.
Injury, poisoning and procedural complications Cervical Vertebral Fracture	1.0% 1/98 • 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% 0/99 • Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.
Surgical and medical procedures Nephrectomy	1.0% 1/98 • 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% 0/99 • Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.
Infections and infestations Appendicitis	0.00% 0/98 • Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.	1.0% 1/99 • Number of events 1 • Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.
Cardiac disorders Angina Pectoris	0.00% 0/98 • Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.	1.0% 1/99 • Number of events 1 • Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.
Cardiac disorders Coronary Artery Disease	0.00% 0/98 • Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.	1.0% 1/99 • Number of events 1 • Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.
Injury, poisoning and procedural complications Rib Fracture	1.0% 1/98 • 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% 0/99 • Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.
Gastrointestinal disorders Impaired Gastric Emptying	0.00% 0/98 • Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.	1.0% 1/99 • Number of events 1 • 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) Uterine Leiomyoma	0.00% 0/98 • Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.	1.0% 1/99 • Number of events 1 • Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.
Vascular disorders Subarachnoid Hemorrhage	1.0% 1/98 • 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% 0/99 • Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.
Congenital, familial and genetic disorders Spondylolisthesis	1.0% 1/98 • 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% 0/99 • Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.
Cardiac disorders Cardiac Arrest	0.00% 0/98 • Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.	1.0% 1/99 • Number of events 1 • Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.