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STYLE -- A Trial of Cell Enriched Adipose For Androgenetic Alopecia (STYLE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02503852
Recruitment Status : Completed
First Posted : July 21, 2015
Results First Posted : January 13, 2020
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Kerastem Technologies, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Alopecia, Androgenetic
Interventions Device: Puregraft System
Device: Celution System
Procedure: Kerastem Therapy
Procedure: Liposuction
Enrollment 71
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Fat + High Dose ADRC Fat + Low Dose ADRC Fat Alone No Fat Control
Hide Arm/Group Description

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.

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.

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.

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.

Period Title: Overall Study
Started 16 22 24 9
Completed 12 19 21 8
Not Completed 4 3 3 1
Arm/Group Title Fat + High Dose ADRC Fat + Low Dose ADRC Fat Alone No Fat Control Total
Hide Arm/Group Description

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.

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.

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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 16 22 24 9 71
Hide Baseline Analysis Population Description
All subjects were included in the analysis population.
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Years
Age(Years) Number Analyzed 16 participants 22 participants 24 participants 9 participants 71 participants
40.0  (9.1) 43.1  (13.3) 40.5  (12.7) 36.1  (5.4) 40.7  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 22 participants 24 participants 9 participants 71 participants
Female
2
  12.5%
5
  22.7%
7
  29.2%
3
  33.3%
17
  23.9%
Male
14
  87.5%
17
  77.3%
17
  70.8%
6
  66.7%
54
  76.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 22 participants 24 participants 9 participants 71 participants
Hispanic or Latino
6
  37.5%
6
  27.3%
12
  50.0%
4
  44.4%
28
  39.4%
Not Hispanic or Latino
8
  50.0%
16
  72.7%
12
  50.0%
5
  55.6%
41
  57.7%
Unknown or Not Reported
2
  12.5%
0
   0.0%
0
   0.0%
0
   0.0%
2
   2.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 22 participants 24 participants 9 participants 71 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
1
   4.2%
0
   0.0%
1
   1.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   6.3%
1
   4.5%
1
   4.2%
0
   0.0%
3
   4.2%
White
15
  93.8%
21
  95.5%
22
  91.7%
9
 100.0%
67
  94.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Safety & Tolerability Assessment of SAE/AE
Hide Description Safety & Tolerability of Experimental Treatment (ADRC) Assessment of SAE/AE
Time Frame Enrollment to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fat + High Dose ADRC Fat + Low Dose ADRC Fat Alone No Fat Control
Hide Arm/Group Description:

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.

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.

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.

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.

Overall Number of Participants Analyzed 16 22 24 9
Measure Type: Number
Unit of Measure: events
Total Number of Adverse Events 5 9 12 2
Unanticipated Adverse Eventss 0 0 0 0
Serious Adverse Events 0 0 0 0
2.Secondary Outcome
Title Terminal (Non-Vellus) Hair Count--Change From Baseline
Hide Description Terminal (Non-Vellus) Hair Count Assessment by Macrophotography
Time Frame Enrollment to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
mITT, Baseline Norwood-Hamilton III
Arm/Group Title Fat + High Dose ADRC Fat + Low Dose ADRC Fat Alone No Fat Control
Hide Arm/Group Description:

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.

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.

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.

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.

Overall Number of Participants Analyzed 6 11 5 4
Mean (Standard Error)
Unit of Measure: Hairs
-5.62  (6.09) 16.2  (4.98) -0.57  (7.53) -7.92  (8.98)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fat + Low Dose ADRC, No Fat Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.032
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Fat + Low Dose ADRC, No Fat Control
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0318
Comments P value cited is the difference in non-vellus hair count between the low-dose ADRC NW3 group and the no-fat saline control at week 24
Method ANCOVA
Comments [Not Specified]
3.Secondary Outcome
Title Hair Satisfaction Questionnaire Responses at Week 24 for Questions 1 Through 4
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The Baseline NW3 subgroup included all male subjects with baseline Norwood Scale III, III-A and III-V.
Arm/Group Title Fat + High Dose ADRC Fat + Low Dose ADRC Fat Alone No Fat Control
Hide Arm/Group Description:

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.

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.

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.

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.

Overall Number of Participants Analyzed 6 7 12 3
Measure Type: Number
Unit of Measure: % of participants with + responses
12.5 34.4 20.8 4.1
Time Frame From Enrollment through 52 Weeks
Adverse Event Reporting Description Events were reported by Investigators, which was supplemented by information from study subjects to Investigators. Attribution was performed by study Medical Director. No adverse Events were attributed to the experimental procedure / product.
 
Arm/Group Title Fat + High Dose ADRC Fat + Low Dose ADRC Fat Alone No Fat Control
Hide Arm/Group Description

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.

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.

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.

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.

All-Cause Mortality
Fat + High Dose ADRC Fat + Low Dose ADRC Fat Alone No Fat Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)      0/22 (0.00%)      0/24 (0.00%)      0/9 (0.00%)    
Hide Serious Adverse Events
Fat + High Dose ADRC Fat + Low Dose ADRC Fat Alone No Fat Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/16 (0.00%)      0/22 (0.00%)      0/24 (0.00%)      0/9 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Fat + High Dose ADRC Fat + Low Dose ADRC Fat Alone No Fat Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/16 (31.25%)      9/22 (40.91%)      11/24 (45.83%)      2/9 (22.22%)    
Immune system disorders         
Shilgles  1  0/16 (0.00%)  0 0/22 (0.00%)  0 1/24 (4.17%)  1 0/9 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Hickups  1  0/16 (0.00%)  0 1/22 (4.55%)  1 0/24 (0.00%)  0 0/9 (0.00%)  0
Skin and subcutaneous tissue disorders         
Brusing or Edema  1 [1]  5/16 (31.25%)  5 8/22 (36.36%)  8 11/24 (45.83%)  11 2/9 (22.22%)  2
1
Term from vocabulary, MedDRA (10.0)
Indicates events were collected by systematic assessment
[1]
At liposuction or donor site, with or without pain
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Eric Daniels, M.D., Chief Medical Officer
Organization: Kerastem
Phone: 858.348.8050
EMail: edaniels@puregraft.com
Layout table for additonal information
Responsible Party: Kerastem Technologies, LLC
ClinicalTrials.gov Identifier: NCT02503852    
Other Study ID Numbers: 003-A-II
First Submitted: July 17, 2015
First Posted: July 21, 2015
Results First Submitted: August 27, 2019
Results First Posted: January 13, 2020
Last Update Posted: January 13, 2020