ADMSCs for the Treatment of Systemic Sclerosis | NCT02975960

Studies
ADMSCs for the Treatment of Systemic Sclerosis

NCT02975960

Sponsor

The Catholic University of Korea

Status

Completed

Last Update Posted

Jan 25, 2018Actual

Enrollment

7Actual

Phase

Not Applicable

Conditions

Systemic Sclerosis

Interventions

injection of autologous stromal vascular fraction

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 25, 2016Actual

Primary Completion Date

Oct 30, 2017Actual

Completion Date

Jan 20, 2018Actual

First Submitted Date

Nov 9, 2016

First Submission Date that Met QC Criteria

Nov 23, 2016

First Posted Date

Nov 29, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 23, 2018

Last Update Posted Date

Jan 25, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jung Hee Koh, Clinical Professor, Principal Investigator, The Catholic University of KoreaPrincipal Investigator

Lead Sponsor

The Catholic University of KoreaOTHER

Collaborators

Name	Class
Seoul St. Mary's Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Stromal vascular fraction injection	Experimental	Injection of autologous stromal vascular fraction on hand.	Biological: injection of autologous stromal vascular fraction

Interventions

Name	Type	Description	Arm Group Labels	Other Names
injection of autologous stromal vascular fraction	Biological	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline modified Rodnan Skin score (mRSS) of hands at 12 weeks	Assess hands mRSS	baseline, 12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline Raynaud's condition score at 12 weeks	The severity (frequency and intensity of crises) of Raynaud's phenomenon	baseline, 12 weeks
Change from baseline Visual Analog Score for pain the hands at 12 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jung Hee Koh, MD	Seoul St.Mary's hospital, The Catholic university of Korea	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul St. Mary's hospital		Seoul		06591	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012595	Scleroderma, Systemic
C000721267	digital ulcers
D005734	Gangrene

Ancestor Terms

ID	Term
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D012871	Skin Diseases
D009336	Necrosis

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Browse Branches

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