Safety of Adipose-Derived Stem Cell Stromal Vascular Fraction
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02590042|
Recruitment Status : Not yet recruiting
First Posted : October 28, 2015
Last Update Posted : July 19, 2017
|Condition or disease||Intervention/treatment||Phase|
|Abnormally Healing Wounds Scars Soft Tissue Defects||Biological: ADSC-SVF-002||Phase 1|
Protocol Number: SJS-CT-001 Phase: Pilot study Methodology: Open label, single-arm Study Duration: Six months after accrual and treatment of the last patient Study Center(s): Single-center Objectives: To demonstrate the safety of subcutaneous administration of autologous ADSC-SVF-002 in a population of subjects with soft tissue defects or abnormal wound healing who are still symptomatic despite being managed by conventional therapies.
Number of Subjects: 10 Diagnosis and Main Inclusion Criteria: Subject has soft tissue deficiencies, soft tissue post traumatic malformations, scars, and/or abnormal wound healing.
Study Product, Dose, Route, Regimen: ADSC-SVF-002. 1.0x106 cells/mL defect (when administered without fat) to 1.2x106 cells/mL defect (when administered with fat). Subcutaneous injection.
Duration of administration: Administration of the product takes approximately 30 minutes. Administered once.
Reference therapy: N/A
Statistical Methodology: Safety outcomes will be reported with descriptive statistics. Secondary (efficacy) outcomes will be assessed relative to baseline (screening) as follows:
- For outcomes assessed at multiple follow-up visits, one-way ANOVAs followed by the Tukey's test will be conducted
- For outcomes assessed at one follow-up visit, a Student's t-test will be conducted.
Data will be reported as mean ± SD and p<0.05 will be considered significant.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Open-labeled, Single-arm, Single-centred Study to Test the Safety of ADSC-SVF-002 in Subjects With Soft Tissue Defects or Abnormal Wound Healing|
|Estimated Study Start Date :||October 2017|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||January 2021|
Cells will be administered at 1x10^6 cells/mL of defect. If administered with fat, the cells will be administered at 1.2x10^6 cells/mL of defect.
ADSC-SVF with the following identity:
Less than or equal to 10% each CD34 and CD45 positive cells At least 70% each CD90, CD73 and CD105 positive cells Viability of at least 85% Mean Florescence Intensity of less than or equal to 100 C12FDG 0-5-2.5x10^6 cells/g of liposuctioned (hydrated fat)
Other Name: ADSC-SVF manufactured by AdiSave
- Continuous monitoring of safety via laboratory tests and physical examinations [ Time Frame: Screening, 48 hours after procedure, and at post-treatment months 1, 2 and 6 ]Continuous monitoring of safety as requested by Health Canada
- Physician satisfaction with wound cosmesis, assessed using the Hollander Wound Evaluation Scale [ Time Frame: Screening, 48 hours after procedure, and at post-treatment day 10 and months 1-6 ]
- Patient satisfaction with wound cosmesis, assessed using the 100 mm vertical line visual analogue scale [ Time Frame: Screening, 48 hours after procedure, and at post-treatment day 10 and months 1-6 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02590042
|Contact: Keren Leibson, PhD||416 email@example.com|
|Forest Hill Institute of Aesthetic Plastic Surgery||Recruiting|
|Toronto, Ontario, Canada, M6C2E3|
|Contact: Sarah HM Wong, MD 416-289-3200 firstname.lastname@example.org|
|Principal Investigator:||Sarah HM Wong, MD||Forest Hill Institute of Aesthetic Plastic Surgery|