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
Sponsor study identifier
interventional
10
1 country
1
Study Start
October 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
October 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2021
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 21, 2015
Actual (reported)October 28, 2015
Actual (reported)October 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 2020
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January 2021
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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
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
Screening, 48 hours after procedure, and at post-treatment day 10 and months 1-6
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.
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)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Forest Hill Institute of Aesthetic Plastic Surgery
Toronto, Ontario, M6C2E3, Canada
Sarah HM Wong, MD
Forest Hill Institute of Aesthetic Plastic Surgery
First Submitted
October 21, 2015
First Posted
October 28, 2015
Study Start
October 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
October 2020
Estimated (date passed)Investigation Into the Safety of Intradermal Juvidex (M6P) Administered to Wounds of Healthy Subjects
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 19, 2017
Record last verified: 2017-07
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Source: ClinicalTrials.gov.
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