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ADMSCs for the Treatment of Systemic Sclerosis

Primary Purpose

Systemic Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
injection of autologous stromal vascular fraction
Sponsored by
The Catholic University of Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Sclerosis focused on measuring systemic sclerosis, adipose derived stem cell, stromal vascular fraction, digital ulcer, gangrene

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients who fulfill 2013 American college of Rheumatology/ European League Against Rheumatism Criteria for the classification of systemic sclerosis.
  2. The skin lesion was not improved after 6 months treatment with conventional therapy.

Exclusion Criteria:

  1. Pregnancy
  2. Start new medications within 3 months prior to enrollment
  3. Previous sympathectomy or amputation
  4. Current systemic infection
  5. AIDS, Syphilis, hepatitis B&C
  6. BMI <17kg/m2
  7. Cognitive dysfunction and other psychologic problems

Sites / Locations

  • Seoul St. Mary's hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stromal vascular fraction injection

Arm Description

Injection of autologous stromal vascular fraction on hand.

Outcomes

Primary Outcome Measures

Change from baseline modified Rodnan Skin score (mRSS) of hands at 12 weeks
Assess hands mRSS

Secondary Outcome Measures

Change from baseline Raynaud's condition score at 12 weeks
The severity (frequency and intensity of crises) of Raynaud's phenomenon
Change from baseline Visual Analog Score for pain the hands at 12 weeks
Patient report hand pain degree, comparing baseline and 12 weeks
Changes from baseline mRSS (total) at 12 weeks
Assess total mRSS (including hands)
Change from baseline Kapandji score at 12weeks
assess the mobility of both hands
Change from baseline Cochin hand function scale at 12 weeks
Assess hand function (patients reported outcome)
Change from baseline Systemic sclerosis HAQ at 12 weeks
he quality of life- score adapted to systemic sclerosis
Change from baseline peripheral vasculature at 12 weeks
Assess peripheral vascularity by Nailfold capillaroscopy
Change from baseline finger circumference at 12 weeks
Measure second to fifth finger circumference

Full Information

First Posted
November 9, 2016
Last Updated
January 23, 2018
Sponsor
The Catholic University of Korea
Collaborators
Seoul St. Mary's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02975960
Brief Title
ADMSCs for the Treatment of Systemic Sclerosis
Official Title
Adipose Tissue-derived Mesenchymal Stem Cells for Cell-based Therapy in the Treatment of Systemic Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
October 25, 2016 (Actual)
Primary Completion Date
October 30, 2017 (Actual)
Study Completion Date
January 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Catholic University of Korea
Collaborators
Seoul St. Mary's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Systemic sclerosis (SSc) is a rare autoimmune disease, mainly characterized by cutaneous and visceral fibrosis. Digital ulcer and sclerosing skin are commonly affected on hands, but the treatment for these manifestations are often ineffective. Adipose tissue contains stromal vascular fraction (SVF), which is abundant multipotent stem cells, capable of tissue repair. A prior study (NCT01813279) has shown the safety and tolerance at 6 months of the subcutaneous injection of SVF in the fingers in SSc. There are only few ways to manage SSc patients with skin lesion who already have treated with several medications (including vasodilators, PDE5 inhibitor, endothelin receptor antagonist) but some times their skin lesions are critical physically and emotionally. Autologous SVF injection could be one of the treatment options to treat skin lesion of SSc. Thus, the investigators study the efficacy and potential adverse event in Korean patients with SSc.
Detailed Description
In this study, the investigators will inject autologous Stromal vascular fraction. 1) Acquiring autologous stromal vascular fraction by plastic surgeon Liposuction Extraction and purifying SVF using Smart-X system (15-20 min) Making syringe filled with autologous SVF 2) SVF injection Inject SVF subcutaneously with 25G needle in finger

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Sclerosis
Keywords
systemic sclerosis, adipose derived stem cell, stromal vascular fraction, digital ulcer, gangrene

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stromal vascular fraction injection
Arm Type
Experimental
Arm Description
Injection of autologous stromal vascular fraction on hand.
Intervention Type
Biological
Intervention Name(s)
injection of autologous stromal vascular fraction
Intervention Description
Acquiring autologous stromal vascular fraction (SVF) from liposuction purifying SVF from lipoaspirates and making syringe filled with SVF SVF injection - Inject SVF on fingers subcutaneously.
Primary Outcome Measure Information:
Title
Change from baseline modified Rodnan Skin score (mRSS) of hands at 12 weeks
Description
Assess hands mRSS
Time Frame
baseline, 12 weeks
Secondary Outcome Measure Information:
Title
Change from baseline Raynaud's condition score at 12 weeks
Description
The severity (frequency and intensity of crises) of Raynaud's phenomenon
Time Frame
baseline, 12 weeks
Title
Change from baseline Visual Analog Score for pain the hands at 12 weeks
Description
Patient report hand pain degree, comparing baseline and 12 weeks
Time Frame
baseline, 12 weeks
Title
Changes from baseline mRSS (total) at 12 weeks
Description
Assess total mRSS (including hands)
Time Frame
baseline, 12 weeks
Title
Change from baseline Kapandji score at 12weeks
Description
assess the mobility of both hands
Time Frame
baseline, 12 weeks
Title
Change from baseline Cochin hand function scale at 12 weeks
Description
Assess hand function (patients reported outcome)
Time Frame
baseline, 12 weeks
Title
Change from baseline Systemic sclerosis HAQ at 12 weeks
Description
he quality of life- score adapted to systemic sclerosis
Time Frame
baseline, 12 weeks
Title
Change from baseline peripheral vasculature at 12 weeks
Description
Assess peripheral vascularity by Nailfold capillaroscopy
Time Frame
baseline, 12 weeks
Title
Change from baseline finger circumference at 12 weeks
Description
Measure second to fifth finger circumference
Time Frame
baseline, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who fulfill 2013 American college of Rheumatology/ European League Against Rheumatism Criteria for the classification of systemic sclerosis. The skin lesion was not improved after 6 months treatment with conventional therapy. Exclusion Criteria: Pregnancy Start new medications within 3 months prior to enrollment Previous sympathectomy or amputation Current systemic infection AIDS, Syphilis, hepatitis B&C BMI <17kg/m2 Cognitive dysfunction and other psychologic problems
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jung Hee Koh, MD
Organizational Affiliation
Seoul St.Mary's hospital, The Catholic university of Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul St. Mary's hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

ADMSCs for the Treatment of Systemic Sclerosis

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