Injection of Autologous Adipose-derived Stromal Vascular Fraction in the Finger of Systemic Sclerosis Patients

NCT03060551 | Completed Early Phase 1 Results

• 1 other identifier: SVF treatment in SSc
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study outlines the safety of the autologous SVF cells injection in the hands of patients with SSc. Preliminary assessments at 6 months will suggest potential efficacy needing confirmation in a randomised placebo-controlled trial on a larger population

Conditions

Systemic Sclerosis

Keywords

stromal vascular fraction; hand disability; mesenchymal stem cells; phase I trial

Outcome Measures

Primary Outcomes (10)

• Raynaud's Condition Scale

  The severity of Raynaud's phenomenon was assessed using the Raynaud's condition scale (ranging 0 to 10, with higher scores representing more severe Raynaud's phenomenon)

  Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks

• Hand Visual Analogue Scale

  Hand pain was assessed using the Hand visual analogue scale (ranging 0 to 10, with higher scores representing more severe pain)

  Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks

• Colchin Hand Function Scale

  The Colchin hand function scale (CHFS, ranging 0 to 90, with higher scores representing more deteriorated hand function) scores

  Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks

• Kapandji Score (Ranging 0 to 10) - Dominant Hand

  Kapandji score (ranging 0 to 10) is validated measures in past studies as outcomes for hand disability. The Kapandji score is a tool useful for assessing the opposition of the thumb, based on where on their hand the patient is able to touch with the tip of their thumb. A score of 0 indicates no opposition, a score of 10 indicates maximal opposition.

  Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks

• Kapandji Score (Non-dominant Hand)

  Kapandji score (ranging 0 to 10) is validated measures in past studies as outcomes for hand disability. The Kapandji score is a tool useful for assessing the opposition of the thumb, based on where on their hand the patient is able to touch with the tip of their thumb. A score of 0 indicates no opposition, a score of 10 indicates maximal opposition.

  Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks

• Disease-related QOL (Quality of Life) : EuroQol-5 Dimensions Time Trade-off (EQ-5D TTO)

  Disease-related QOL (quality of life) was measured by EuroQol-5 dimensions time trade-off (EQ-5D TTO, ranging 0 to 1, with higher values representing better QOL) values

  Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks

• Disease-related QOL (Quality of Life) : EuroQol Visual Analog Scale (EQ VAS)

  Disease-related QOL (quality of life) : EuroQol visual analog scale (EQ VAS, ranging 0 to 100, with higher scores representing better QOL)

  Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks

• Disease-related QOL (Quality of Life) : Health Assessment Questionnaire (HAQ)

  Disease-related QOL (quality of life) : health assessment questionnaire (HAQ, ranging 0 to 3, with higher scores meaning lower QOL)

  Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks

• The Degree of Hand Edema (Right)

  The finger circumferences of the second to the fifth fingers measured in the middle portion of each proximal phalanx were used to assess the degree of hand edema

  Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks

• The Degree of Hand Edema (Left)

  The finger circumferences of the second to the fifth fingers measured in the middle portion of each proximal phalanx were used to assess the degree of hand edema

  Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks

Secondary Outcomes (6)

• Changes of Nailfold Capillary Microscopic Findings (Irregularly Enlarged Capillaries)

  Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks

• Changes of Nailfold Capillary Microscopic Findings (Giant Capillaries)

  Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks

• Changes of Nailfold Capillary Microscopic Findings (Hemorrhages)

  Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks

• Changes of Nailfold Capillary Microscopic Findings (Loss of Capillaries)

  Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks

• Changes of Nailfold Capillary Microscopic Findings (Disorganization of the Vascular Array)

  Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks

Study Arms (1)

SVF injection

EXPERIMENTAL

SVF was obtained from lipoaspirates, using an automated processing system, and subsequently injected into the subcutaneous tissue of each finger in contact with neurovascular pedicles

Procedure: SVF injection

Interventions

SVF injection PROCEDURE

SVF is increasingly recognised as an easily accessible source of regenerative cells with therapeutic potential in ischaemic or autoimmune disease. We aimed to measure for the first time the safety, tolerability and potential efficacy of autologous SVF cells local injections in patients with systemic sclerosis

SVF injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age over 18 year old
• Cochin Hand Function Scale (CHFS) \> 20/90

You may not qualify if:

• new vasodilators or immunosuppressive therapy for SSc in the 3 months prior to enrolment
• new vasodilators or immunosuppressive therapy for SSc during the 6-month follow-up
• clinical or radiological signs of digital infection
• positive status for HIV
• positive status for hepatitis B or C
• positive status for human T-cell leukemia virus 1-2
• positive status for syphilis
• pregnancy
• BMI less than 17kg/m2

Sponsors & Collaborators

• Suk-Ho Moon: lead

Study Sites (1)

Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea

Seoul, South Korea

Location

Related Publications (1)

• Park Y, Lee YJ, Koh JH, Lee J, Min HK, Kim MY, Kim KJ, Lee SJ, Rhie JW, Kim WU, Park SH, Moon SH, Kwok SK. Clinical Efficacy and Safety of Injection of Stromal Vascular Fraction Derived from Autologous Adipose Tissues in Systemic Sclerosis Patients with Hand Disability: A Proof-Of-Concept Trial. J Clin Med. 2020 Sep 19;9(9):3023. doi: 10.3390/jcm9093023.

  PMID: 32961802 DERIVED

MeSH Terms

Conditions

Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Results Point of Contact

• Title: Suk-Ho Moon
• Organization: Department of Plastic Surgery, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea

nasuko@catholic.ac.kr

821090803527

Study Officials

• Suk-Ho Moon, MD, PhD

  Seoul St. Mary's Hospital

  STUDY DIRECTOR

• Seung-Ki Kwok

  Seoul St. Mary's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Systemic sclerosis patients with hand disability, planning 24 weeks of follow-up period Autologous adipose tissue-derived stromal vascular fraction(SVF) injected into the subcutaneous tissue of each finger in contact with neurovascular pedicles.

Study Record Dates

• First Submitted: November 9, 2016
• First Posted: February 23, 2017
• Study Start: July 1, 2018
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: October 8, 2020
• Results First Posted: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)