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

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ClinicalTrials.gov Identifier: NCT03060551
Recruitment Status : Active, not recruiting
First Posted : February 23, 2017
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Suk-Ho Moon, Seoul St. Mary's Hospital

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

Condition or disease Intervention/treatment Phase
Systemic Sclerosis Procedure: SVF injection Early Phase 1

Detailed Description:
In patients with systemic sclerosis(scleroderma, SSc), impaired hand function greatly contributes to disability and reduced quality of life, and is insufficiently relived by currently available therapies. Adipose tissue-derived stromal vascular fraction (SVF) is increasingly recognized as an easily accessible source of regenerative cells with therapeutic potential in ischaemic or autoimmune disease. The investigators aimed to measure for the first time the safety, tolerability, and potential efficacy of autologous SVF cells local injections in patients with SSc with hand disability.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Autologous adipose tissue-derived stromal vascular fraction(SVF) injected into the subcutaneous tissue of each finger in contact with neurovascular pedicles.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety, Tolerability and Potential Efficacy of Injection of Autologous Adipose-derived Stromal Vascular Fraction in the Finger of Systemic Sclerosis Patients
Study Start Date : October 2016
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scleroderma

Arm Intervention/treatment
Experimental: SVF injection
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
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




Primary Outcome Measures :
  1. The pain scale of the patient (VAS score) [ Time Frame: 6 months after injection ]
    Visual Analog Pain Scale (VAS) score


Secondary Outcome Measures :
  1. The function of the hand (Cochin Hand Function scale) [ Time Frame: 6 months after injection ]
    Cochin Hand Function scale (CHFS)

  2. The function of the hand (Kapandji score) [ Time Frame: 6 months after injection ]
    Kapandji score

  3. The vascular change in the hand of the patient (Raynaud's condition score) [ Time Frame: 6 months after injection ]
    Raynaud's condition score (RCS)

  4. The vascular change in the hand of the patient (Nailfold capillary microscopy) [ Time Frame: 6 months after injection ]
    Nailfold capillary microscopy



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03060551


Sponsors and Collaborators
Suk-Ho Moon
Investigators
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Study Director: Suk-Ho Moon, MD, PhD Seoul St. Mary's Hospital

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Responsible Party: Suk-Ho Moon, Assistant Professor, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier: NCT03060551     History of Changes
Other Study ID Numbers: SVF treatment in SSc
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Sclerosis
Scleroderma, Systemic
Scleroderma, Diffuse
Pathologic Processes
Connective Tissue Diseases
Skin Diseases