Alopecia, Androgenetic
Conditions
Keywords
Female Pattern Baldness, Male Pattern Baldness, Genetic Alopecia, Androgenic Alopecia, Hair Loss
Brief summary
The primary objective of this study is to evaluate the safety and feasibility of the Celution and Puregraft Systems in the processing and preparation of an autologous fat graft enriched with adipose-derived regenerative cells (ADRCs) in the treatment of early alopecia androgenetica.
Detailed description
The STYLE Trial is a prospective, randomized, multi-center device trial intended to evaluate the safety and efficacy of the Celution and Puregraft Systems in the processing and preparation of an autologous fat graft enriched with adipose-derived regenerative cells (ADRCs) in the treatment of early alopecia androgenetica. Patients may be included if they are undergoing an elective cosmetic liposuction. Following informed consent and screening evaluations, eligible subjects will undergo pre-operative testing. Subjects will then undergo a fat harvest using local anesthesia with or without conscious sedating. Subjects will be randomly assigned to receive a fat graft cell enriched with ADRCs (available in two different doses),a fat graft without cell enrichment using a visually-matched blood saline solution (fat alone control), or a saline injection (no-fat control) in a 2:2:2:1 ratio. While undergoing liposuction, lipoaspirate will be processed in the Puregraft System to remove the lipoaspirate of impurities and in the Celution System to isolate and concentrate ADRCs. After the liposuction is completed), patients will have, under a ring block local anesthesia (see further description below), a subcutaneous scalp injection of either Puregraft purified autologous fat or saline (no-fat control) followed by a separate second injection, of either ADRCs (available in two different doses),a visually-matched blood saline solution (fat alone control), or saline (no-fat control) in a 2:2:2:1 ratio. The STYLE Clinical Trial will have a sample size of 70 patients at up to eight (8) centers.
Interventions
DEVICEPuregraft System
The Puregraft System prepares purified adipose tissue for subcutaneous scalp injection.
DEVICECelution System
The Celution System prepares adipose derived regenerative cells (ADRCs) for subcutaneous scalp injection.
PROCEDUREKerastem Therapy
The Kerastem Therapy is the subcutaneous scalp injection of purified adipose prepared with the Puregraft System enriched with ADRCs prepared from the Celution System.
PROCEDURELiposuction
Tissue collection involving the micro-harvest of subcutaneous adipose tissue.
Sponsors
Kerastem Technologies, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Randomization via manual treatment assignment by the unblinded Clinical Supply Manager prior to the start of liposuction. Subjects randomized into the study are assigned their study Arm corresponding to the next available number in the computer-generated randomization schedule. Dose preparation ios performed by designated unblinded qualified personnel and supplied to the blinded treating team.
Intervention model description
Subjects arm randomized prior to liposuction 2:2:2:1 ratio to one of 4 Arms. Low Dose ADR, High Dose ADRC, non enriched fat only, and no fat (control normal saline).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Males with a diagnosis of Alopecia Androgenetica 2. Females with a diagnosis of Alopecia Androgenetica 3. Males with hair loss consistent with Grades III, IIIA, III-Vertex, IV, IV-A, based on Norwood-Hamilton Scale (Figure 1) 4. Females with hair loss consistent with Grades I-3, I-4, II-1, II-2 based on the Savin Scale (Figure 2) 5. Provide written informed consent and comply with the study requirements 6. For women of childbearing potential: Negative pregnancy test at screening visit plus subject agrees to maintain two forms of contraception for the duration of the study. 7. Subject is willing to maintain a consistent hair length and natural hair color, without the use of any coloring agents, during the study period. 8. Ability to complete study procedures, patient surveys, and pictures. 9. Subject is ≥ 18 years of age. 10. Body Mass Index \< 40kg/m2
Exclusion criteria
1. Subjects who have used minoxidil, or any oral or topical medication including over the counter and herbal medications for the treatment of hair loss within 6 months of study screening, or finasteride or dutasteride within 12 months of study screening 2. Treatment with an investigational product or procedure within 30 days or plans to participate in another clinical study 3. Subject who has previously failed or has been deemed non-responsive to a previous experimental hair loss treatment. 4. Subject must have no previous hair transplant, cell treatment, micro needling, or any other treatment in the last 6 months in the scalp. 5. Subject is currently suffering from an active autoimmune disease such as serum lupus erythematosus, or alopecia areata. Subject is currently suffering from dermatologic condition in the treatment area or has a significant scar in the hair treatment area that, in the opinion of the investigator, will make hair growth difficult (such as systemic burns, etc.). 6. History of autoimmune disease or organ transplantation or a patient on immunosuppressive medication(s). 7. Diagnosis of cancer, receiving active treatment 8. Active systemic infection 9. Requires chronic antibiotics, systemic corticosteroids 10. Use of systemic agents that increase bleeding or clotting, or disorders associated with these effects, including patients receiving GIIB/IIIa inhibitors within 2 weeks prior to the study procedure through to 1 week after the study procedure. 11. Clinically significant medical or psychiatric illness currently or within 30 days of study screening as determined by the investigator 12. Prior surgery in the treatment area 13. Any disease or condition (medical or surgical) that, in the opinion of the investigator, might compromise dermatologic, hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, or central nervous system function; or any condition that would place the subject at increased risk 14. Pregnant or lactating women or women trying to become pregnant 15. Known allergic reaction to components of study treatment and/or study injection procedure 16. Subject has any disorder that may prevent compliance to study procedures and visits 17. Subject who is part of the study staff, a family member or friend 18. Diabetes or thyroid disorder 19. Subject who has a sensitive, irritated, or abraded scalp area. 20. Women who have an alternate diagnosis that is associated with hair loss. 21. Body Mass Index \< 18kg/m2 22. Clinically significant abnormal findings on laboratory screening panels, including hemoglobin ≤ 10 g/dL. 23. Hepatic dysfunction, as defined as aspartate aminotransferase (AST), alanine aminotransferase (ALT), or bilirubin levels \> 1.5 times the upper limit of normal range (x ULN) prior to randomization. 24. Chronic renal insufficiency as defined as a serum creatinine \> 1.2 mg/dL for women and \> 1.5 mg/dL for men. 25. An elevated PT/PTT, INR, or platelet count \< 100 x 109/L
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety & Tolerability Assessment of SAE/AE | Enrollment to 52 weeks | Safety & Tolerability of Experimental Treatment (ADRC) Assessment of SAE/AE |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Terminal (Non-Vellus) Hair Count--Change From Baseline | Enrollment to 52 weeks | Terminal (Non-Vellus) Hair Count Assessment by Macrophotography |
| Hair Satisfaction Questionnaire Responses at Week 24 for Questions 1 Through 4 | Enrollment to 24 weeks | Percent of positive responses, defined by increase of 1 or more from baseline, on specific written assessment of treatment outcome by Investigators scored 1-5, value 1 is lowest, value of 5 is highest, higher values represent more positive responses |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fat + High Dose ADRC Kerastem Therapy includes micro-liposuction followed by subcutaneous scalp injection of purified adipose prepared with the Puregraft System + 1,000,000 ADRC prepared with the Celution System per square centimeter of scalp.
Puregraft System: The Puregraft System prepares purified adipose tissue for subcutaneous scalp injection.
Celution System: The Celution System prepares adipose derived regenerative cells (ADRCs) for subcutaneous scalp injection.
Kerastem Therapy: The Kerastem Therapy is the subcutaneous scalp injection of purified adipose prepared with the Puregraft System enriched with ADRCs prepared from the Celution System.
Liposuction: Tissue collection involving the micro-harvest of subcutaneous adipose tissue. | 16 |
| Fat + Low Dose ADRC Kerastem Therapy includes micro-liposuction followed by subcutaneous scalp injection of purified adipose prepared with the Puregraft System + 500,000 ADRC prepared with the Celution System per square centimeter of scalp.
Puregraft System: The Puregraft System prepares purified adipose tissue for subcutaneous scalp injection.
Celution System: The Celution System prepares adipose derived regenerative cells (ADRCs) for subcutaneous scalp injection.
Kerastem Therapy: The Kerastem Therapy is the subcutaneous scalp injection of purified adipose prepared with the Puregraft System enriched with ADRCs prepared from the Celution System.
Liposuction: Tissue collection involving the micro-harvest of subcutaneous adipose tissue. | 22 |
| Fat Alone Micro-liposuction followed by subcutaneous scalp injection of purified adipose prepared with the Puregraft System per square centimeter of scalp.
Puregraft System: The Puregraft System prepares purified adipose tissue for subcutaneous scalp injection.
Liposuction: Tissue collection involving the micro-harvest of subcutaneous adipose tissue. | 24 |
| No Fat Control Micro-liposuction followed by subcutaneous scalp injection of normal saline per square centimeter of scalp.
Liposuction: Tissue collection involving the micro-harvest of subcutaneous adipose tissue. | 9 |
| Total | 71 |
Baseline characteristics
| Characteristic | Fat + High Dose ADRC | Fat + Low Dose ADRC | Fat Alone | No Fat Control | Total |
|---|---|---|---|---|---|
| Age, Customized Age(Years) | 40.0 years STANDARD_DEVIATION 9.1 | 43.1 years STANDARD_DEVIATION 13.3 | 40.5 years STANDARD_DEVIATION 12.7 | 36.1 years STANDARD_DEVIATION 5.4 | 40.7 years STANDARD_DEVIATION 11.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 6 Participants | 12 Participants | 4 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 16 Participants | 12 Participants | 5 Participants | 41 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 21 Participants | 22 Participants | 9 Participants | 67 Participants |
| Sex: Female, Male Female | 2 Participants | 5 Participants | 7 Participants | 3 Participants | 17 Participants |
| Sex: Female, Male Male | 14 Participants | 17 Participants | 17 Participants | 6 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 22 | 0 / 24 | 0 / 9 |
| other Total, other adverse events | 5 / 16 | 9 / 22 | 11 / 24 | 2 / 9 |
| serious Total, serious adverse events | 0 / 16 | 0 / 22 | 0 / 24 | 0 / 9 |
Outcome results
Primary
Safety & Tolerability Assessment of SAE/AE
Safety & Tolerability of Experimental Treatment (ADRC) Assessment of SAE/AE
Time frame: Enrollment to 52 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fat + High Dose ADRC | Safety & Tolerability Assessment of SAE/AE | Total Number of Adverse Events | 5 events |
| Fat + High Dose ADRC | Safety & Tolerability Assessment of SAE/AE | Serious Adverse Events | 0 events |
| Fat + High Dose ADRC | Safety & Tolerability Assessment of SAE/AE | Unanticipated Adverse Eventss | 0 events |
| Fat + Low Dose ADRC | Safety & Tolerability Assessment of SAE/AE | Total Number of Adverse Events | 9 events |
| Fat + Low Dose ADRC | Safety & Tolerability Assessment of SAE/AE | Serious Adverse Events | 0 events |
| Fat + Low Dose ADRC | Safety & Tolerability Assessment of SAE/AE | Unanticipated Adverse Eventss | 0 events |
| Fat Alone | Safety & Tolerability Assessment of SAE/AE | Unanticipated Adverse Eventss | 0 events |
| Fat Alone | Safety & Tolerability Assessment of SAE/AE | Total Number of Adverse Events | 12 events |
| Fat Alone | Safety & Tolerability Assessment of SAE/AE | Serious Adverse Events | 0 events |
| No Fat Control | Safety & Tolerability Assessment of SAE/AE | Total Number of Adverse Events | 2 events |
| No Fat Control | Safety & Tolerability Assessment of SAE/AE | Serious Adverse Events | 0 events |
| No Fat Control | Safety & Tolerability Assessment of SAE/AE | Unanticipated Adverse Eventss | 0 events |
Secondary
Hair Satisfaction Questionnaire Responses at Week 24 for Questions 1 Through 4
Percent of positive responses, defined by increase of 1 or more from baseline, on specific written assessment of treatment outcome by Investigators scored 1-5, value 1 is lowest, value of 5 is highest, higher values represent more positive responses
Time frame: Enrollment to 24 weeks
Population: The Baseline NW3 subgroup included all male subjects with baseline Norwood Scale III, III-A and III-V.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fat + High Dose ADRC | Hair Satisfaction Questionnaire Responses at Week 24 for Questions 1 Through 4 | 12.5 % of participants with + responses |
| Fat + Low Dose ADRC | Hair Satisfaction Questionnaire Responses at Week 24 for Questions 1 Through 4 | 34.4 % of participants with + responses |
| Fat Alone | Hair Satisfaction Questionnaire Responses at Week 24 for Questions 1 Through 4 | 20.8 % of participants with + responses |
| No Fat Control | Hair Satisfaction Questionnaire Responses at Week 24 for Questions 1 Through 4 | 4.1 % of participants with + responses |
Secondary
Terminal (Non-Vellus) Hair Count--Change From Baseline
Terminal (Non-Vellus) Hair Count Assessment by Macrophotography
Time frame: Enrollment to 52 weeks
Population: mITT, Baseline Norwood-Hamilton III
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fat + High Dose ADRC | Terminal (Non-Vellus) Hair Count--Change From Baseline | -5.62 Hairs | Standard Error 6.09 |
| Fat + Low Dose ADRC | Terminal (Non-Vellus) Hair Count--Change From Baseline | 16.2 Hairs | Standard Error 4.98 |
| Fat Alone | Terminal (Non-Vellus) Hair Count--Change From Baseline | -0.57 Hairs | Standard Error 7.53 |
| No Fat Control | Terminal (Non-Vellus) Hair Count--Change From Baseline | -7.92 Hairs | Standard Error 8.98 |
p-value: 0.032ANCOVA
Comparison: Non-vellus hair count in the low-dose ADRC group in the NW3 subgroup beginning at Week 6 (mean change from baseline persisting through weeks 12 , 24, and 52.p-value: 0.0318ANCOVA