ADMSCs for the Treatment of Systemic Sclerosis

NCT ID: NCT02975960

Last Updated: 2018-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-25
• Study Completion Date: 2018-01-20

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

1. Liposuction

2. Extraction and purifying SVF using Smart-X system (15-20 min)

3. Making syringe filled with autologous SVF

2) SVF injection

Inject SVF subcutaneously with 25G needle in finger

Conditions

Systemic Sclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stromal vascular fraction injection

Injection of autologous stromal vascular fraction on hand.

Group Type: EXPERIMENTAL

injection of autologous stromal vascular fraction

Intervention Type: BIOLOGICAL

1. Acquiring autologous stromal vascular fraction (SVF) from liposuction

2. purifying SVF from lipoaspirates and making syringe filled with SVF

3. SVF injection - Inject SVF on fingers subcutaneously.

Interventions

injection of autologous stromal vascular fraction

1. Acquiring autologous stromal vascular fraction (SVF) from liposuction

2. purifying SVF from lipoaspirates and making syringe filled with SVF

3. SVF injection - Inject SVF on fingers subcutaneously.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul St. Mary's Hospital

OTHER

Sponsor Role: collaborator

The Catholic University of Korea

OTHER

Sponsor Role: lead

Responsible Party

Jung Hee Koh

Clinical Professor, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jung Hee Koh, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul St.Mary's hospital, The Catholic university of Korea

Locations

Seoul St. Mary's hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

KC16TISI0343

Identifier Type: -

Identifier Source: org_study_id