NCT02590042

Safety of Adipose-Derived Stem Cell Stromal Vascular Fraction

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: AdiSave Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Abnormally Healing Wounds
• Scars
• Soft Tissue Defects

Interventions

Type	Name	Description
BIOLOGICAL	ADSC-SVF-002	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)

Timeline

• Start date: 2017-10-01
• Primary completion: 2020-10-01
• Completion: 2021-01-01
• First posted: 2015-10-28
• Last updated: 2017-07-19

Locations

1 site across 1 country: Canada