A single-arm, open-labeled, single-center, descriptive and exploratory safety trial using ADSC-SVF-002. ADSC-SVF-002 is an autologous adipose derived stem cell (ADSC)-containing stromal vascular fraction (SVF) obtained from subcutaneous fat harvested by liposuction from a patient. As a cellular therapy product, ADSC-SVF-002 (fresh or cryopreserved) will be administered subcutaneously via injection, with or without unprocessed autologous fat (fresh or cryopreserved), into soft tissue defects and abnormally healing wounds. The primary objective of the trial is to demonstrate the safety of 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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
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)
Forest Hill Institute of Aesthetic Plastic Surgery
Toronto, Ontario, Canada
Continuous monitoring of safety via laboratory tests and physical examinations
Continuous monitoring of safety as requested by Health Canada
Time frame: Screening, 48 hours after procedure, and at post-treatment months 1, 2 and 6
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.