ADMSCs for the Treatment of Systemic Sclerosis

Systemic Sclerosis Clinical Trial

Official title:

Adipose Tissue-derived Mesenchymal Stem Cells for Cell-based Therapy in the Treatment of Systemic Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02975960
• Other study ID #: KC16TISI0343
• Status: Completed
• Phase: N/A
• First received: November 9, 2016
• Last updated: January 23, 2018
• Start date: October 25, 2016
• Est. completion date: January 20, 2018

Study information

• Verified date: January 2018
• Source: The Catholic University of Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: January 20, 2018
• Est. primary completion date: October 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Intervention

Biological:
• injection of autologous stromal vascular fraction
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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul St. Mary's hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
The Catholic University of Korea	Seoul St. Mary's Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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