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Safety of Adipose-Derived Stem Cell Stromal Vascular Fraction

NCT02590042 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2017-07-19

No results posted yet for this study

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.

Conditions

  • Abnormally Healing Wounds
  • Scars
  • Soft Tissue Defects

Interventions

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)

Sponsors & Collaborators

  • AdiSave Inc.

    lead INDUSTRY

Principal Investigators

  • Sarah HM Wong, MD · Forest Hill Institute of Aesthetic Plastic Surgery

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-31
Primary Completion
2020-10-31
Completion
2021-01-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02590042 on ClinicalTrials.gov