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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:
Data will be reported as mean ± SD and p<0.05 will be considered significant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADSC-SVF-002 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADSC-SVF-002 | Biological | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Continuous monitoring of safety via laboratory tests and physical examinations | Continuous monitoring of safety as requested by Health Canada | Screening, 48 hours after procedure, and at post-treatment months 1, 2 and 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Physician satisfaction with wound cosmesis, assessed using the Hollander Wound Evaluation Scale | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Keren Leibson, PhD | Contact | 416 785-7536 | info@adisave.com |
| Name | Affiliation | Role |
|---|---|---|
| Sarah HM Wong, MD | Forest Hill Institute of Aesthetic Plastic Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Forest Hill Institute of Aesthetic Plastic Surgery | Toronto | Ontario | M6C2E3 | Canada |
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| ID | Term |
|---|---|
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Screening, 48 hours after procedure, and at post-treatment day 10 and months 1-6 |