Safety of Adipose-Derived Stem Cell Stromal Vascular Fraction

Scars Clinical Trial

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

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Abnormally Healing Wounds
• Scars
• Soft Tissue Defects

• NCT number: NCT02590042
• Study type: Interventional
• Source: AdiSave Inc.
• Contact: Keren Leibson, PhD
• Phone: 416 785-7536
• Email: info@adisave.com
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: October 2017
• Completion date: January 2021