An interventional study of Puregraft System and Celution System in Alopecia, Androgenetic, sponsored by Kerastem Technologies, LLC. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-13.
Sponsored by Kerastem Technologies, LLC · Not applicable, Interventional, and Treatment
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.
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.
609 studies on the registry are indexed under Alopecia; 131 are open to participants now.
This study's enrollment of 71 is above the median of 45 across 513 interventional studies indexed under Alopecia.
Browse Alopecia studies →This is the only study on the registry with Kerastem Technologies, LLC as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: Puregraft System · Device: Celution System · Procedure: Kerastem Therapy · Procedure: Liposuction
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.
Device: Puregraft System · Device: Celution System · Procedure: Kerastem Therapy · Procedure: Liposuction
Micro-liposuction followed by subcutaneous scalp injection of purified adipose prepared with the Puregraft System per square centimeter of scalp.
Device: Puregraft System · Procedure: Liposuction
Micro-liposuction followed by subcutaneous scalp injection of normal saline per square centimeter of scalp.
Procedure: Liposuction
The Puregraft System prepares purified adipose tissue for subcutaneous scalp injection.
The Celution System prepares adipose derived regenerative cells (ADRCs) for subcutaneous scalp injection.
The Kerastem Therapy is the subcutaneous scalp injection of purified adipose prepared with the Puregraft System enriched with ADRCs prepared from the Celution System.
Tissue collection involving the micro-harvest of subcutaneous adipose tissue.
Safety & Tolerability Assessment of SAE/AE
Safety \& Tolerability of Experimental Treatment (ADRC) Assessment of SAE/AE
Time frame: Enrollment to 52 weeks
Terminal (Non-Vellus) Hair Count--Change From Baseline
Terminal (Non-Vellus) Hair Count Assessment by Macrophotography
Time frame: Enrollment to 52 weeks
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
| Milestone | Fat + High Dose ADRC | Fat + Low Dose ADRC | Fat Alone | No Fat Control |
|---|---|---|---|---|
| Started | 16 | 22 | 24 | 9 |
| Completed | 12 | 19 | 21 | 8 |
| Not completed | 4 | 3 | 3 | 1 |
Safety \& Tolerability of Experimental Treatment (ADRC) Assessment of SAE/AE
| events | Fat + High Dose ADRC | Fat + Low Dose ADRC | Fat Alone | No Fat Control |
|---|---|---|---|---|
| Total Number of Adverse Events | 5 | 9 | 12 | 2 |
| Unanticipated Adverse Eventss | 0 | 0 | 0 | 0 |
| Serious Adverse Events | 0 | 0 | 0 | 0 |
Terminal (Non-Vellus) Hair Count Assessment by Macrophotography
| Hairs | Fat + High Dose ADRC | Fat + Low Dose ADRC | Fat Alone | No Fat Control |
|---|---|---|---|---|
| Terminal (Non-Vellus) Hair Count--Change From Baseline | -5.62 ± 6.09 | 16.2 ± 4.98 | -0.57 ± 7.53 | -7.92 ± 8.98 |
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
| % of participants with + responses | Fat + High Dose ADRC | Fat + Low Dose ADRC | Fat Alone | No Fat Control |
|---|---|---|---|---|
| Hair Satisfaction Questionnaire Responses at Week 24 for Questions 1 Through 4 | 12.5 | 34.4 | 20.8 | 4.1 |
Collected over From Enrollment through 52 Weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fat + High Dose ADRC | 0/16 (0%) | 0/16 (0%) | 5/16 (31.3%) |
| Fat + Low Dose ADRC | 0/22 (0%) | 0/22 (0%) | 9/22 (40.9%) |
| Fat Alone | 0/24 (0%) | 0/24 (0%) | 11/24 (45.8%) |
| No Fat Control | 0/9 (0%) | 0/9 (0%) | 2/9 (22.2%) |
| Event | Fat + High Dose ADRC | Fat + Low Dose ADRC | Fat Alone | No Fat Control |
|---|---|---|---|---|
| Brusing or EdemaSkin and subcutaneous tissue disorders | 5/16 | 8/22 | 11/24 | 2/9 |
| HickupsRespiratory, thoracic and mediastinal disorders | 0/16 | 1/22 | 0/24 | 0/9 |
| ShilglesImmune system disorders | 0/16 | 0/22 | 1/24 | 0/9 |
All subjects were included in the analysis population.
| Age, Customized(years) | Fat + High Dose ADRC | Fat + Low Dose ADRC | Fat Alone | No Fat Control | Total |
|---|---|---|---|---|---|
| Age(Years) | 40.0 ± 9.1 | 43.1 ± 13.3 | 40.5 ± 12.7 | 36.1 ± 5.4 | 40.7 ± 11.5 |
| Sex: Female, Male(Participants) | Fat + High Dose ADRC | Fat + Low Dose ADRC | Fat Alone | No Fat Control | Total |
|---|---|---|---|---|---|
| Female | 2 | 5 | 7 | 3 | 17 |
| Male | 14 | 17 | 17 | 6 | 54 |
| Ethnicity (NIH/OMB)(Participants) | Fat + High Dose ADRC | Fat + Low Dose ADRC | Fat Alone | No Fat Control | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 6 | 6 | 12 | 4 | 28 |
| Not Hispanic or Latino | 8 | 16 | 12 | 5 | 41 |
| Unknown or Not Reported | 2 | 0 | 0 | 0 | 2 |
| Race (NIH/OMB)(Participants) | Fat + High Dose ADRC | Fat + Low Dose ADRC | Fat Alone | No Fat Control | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 1 | 0 | 3 |
| White | 15 | 21 | 22 | 9 | 67 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
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