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

Systemic Sclerosis Clinical Trial

Official title:

Safety, Tolerability and Potential Efficacy of Injection of Autologous Adipose-derived Stromal Vascular Fraction in the Finger of Systemic Sclerosis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03060551
• Other study ID #: SVF treatment in SSc
• Status: Completed
• Phase: Early Phase 1
• Start date: July 1, 2018
• Est. completion date: December 30, 2019

Study information

• Verified date: October 2020
• Source: Seoul St. Mary's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Suk-Ho Moon

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Raynaud's Condition Scale	The severity of Raynaud's phenomenon was assessed using the Raynaud's condition scale (ranging 0 to 10, with higher scores representing more severe Raynaud's phenomenon)	Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
Primary	Hand Visual Analogue Scale	Hand pain was assessed using the Hand visual analogue scale (ranging 0 to 10, with higher scores representing more severe pain)	Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
Primary	Colchin Hand Function Scale	The Colchin hand function scale (CHFS, ranging 0 to 90, with higher scores representing more deteriorated hand function) scores	Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
Primary	Kapandji Score (Ranging 0 to 10) - Dominant Hand	Kapandji score (ranging 0 to 10) is validated measures in past studies as outcomes for hand disability. The Kapandji score is a tool useful for assessing the opposition of the thumb, based on where on their hand the patient is able to touch with the tip of their thumb. A score of 0 indicates no opposition, a score of 10 indicates maximal opposition.	Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
Primary	Kapandji Score (Non-dominant Hand)	Kapandji score (ranging 0 to 10) is validated measures in past studies as outcomes for hand disability. The Kapandji score is a tool useful for assessing the opposition of the thumb, based on where on their hand the patient is able to touch with the tip of their thumb. A score of 0 indicates no opposition, a score of 10 indicates maximal opposition.	Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
Primary	Disease-related QOL (Quality of Life) : EuroQol-5 Dimensions Time Trade-off (EQ-5D TTO)	Disease-related QOL (quality of life) was measured by EuroQol-5 dimensions time trade-off (EQ-5D TTO, ranging 0 to 1, with higher values representing better QOL) values	Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
Primary	Disease-related QOL (Quality of Life) : EuroQol Visual Analog Scale (EQ VAS)	Disease-related QOL (quality of life) : EuroQol visual analog scale (EQ VAS, ranging 0 to 100, with higher scores representing better QOL)	Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
Primary	Disease-related QOL (Quality of Life) : Health Assessment Questionnaire (HAQ)	Disease-related QOL (quality of life) : health assessment questionnaire (HAQ, ranging 0 to 3, with higher scores meaning lower QOL)	Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
Primary	The Degree of Hand Edema (Right)	The finger circumferences of the second to the fifth fingers measured in the middle portion of each proximal phalanx were used to assess the degree of hand edema	Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
Primary	The Degree of Hand Edema (Left)	The finger circumferences of the second to the fifth fingers measured in the middle portion of each proximal phalanx were used to assess the degree of hand edema	Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
Secondary	Changes of Nailfold Capillary Microscopic Findings (Irregularly Enlarged Capillaries)	In order to assess the severity of microangiopathies in both fingers, a semiquantitative scoring system for nailfold capillary microscopic findings was adopted. A total of six parameters (irregularly enlarged capillaries, giant capillaries, hemorrhages, loss of capillaries, disorganization of the vascular array and capillary ramifications) were measured using the semiquantitative manner on the scale ranging 0 to 3, indicating more severe as scores were higher. Each parameter was scored for four fingers of both hands, except thumbs, and the median score value of each parameter in both hands was finally presented.	Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
Secondary	Changes of Nailfold Capillary Microscopic Findings (Giant Capillaries)	In order to assess the severity of microangiopathies in both fingers, a semiquantitative scoring system for nailfold capillary microscopic findings was adopted. A total of six parameters (irregularly enlarged capillaries, giant capillaries, hemorrhages, loss of capillaries, disorganization of the vascular array and capillary ramifications) were measured using the semiquantitative manner on the scale ranging 0 to 3, indicating more severe as scores were higher. Each parameter was scored for four fingers of both hands, except thumbs, and the median score value of each parameter in both hands was finally presented.	Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
Secondary	Changes of Nailfold Capillary Microscopic Findings (Hemorrhages)	In order to assess the severity of microangiopathies in both fingers, a semiquantitative scoring system for nailfold capillary microscopic findings was adopted. A total of six parameters (irregularly enlarged capillaries, giant capillaries, hemorrhages, loss of capillaries, disorganization of the vascular array and capillary ramifications) were measured using the semiquantitative manner on the scale ranging 0 to 3, indicating more severe as scores were higher. Each parameter was scored for four fingers of both hands, except thumbs, and the median score value of each parameter in both hands was finally presented.	Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
Secondary	Changes of Nailfold Capillary Microscopic Findings (Loss of Capillaries)	In order to assess the severity of microangiopathies in both fingers, a semiquantitative scoring system for nailfold capillary microscopic findings was adopted. A total of six parameters (irregularly enlarged capillaries, giant capillaries, hemorrhages, loss of capillaries, disorganization of the vascular array and capillary ramifications) were measured using the semiquantitative manner on the scale ranging 0 to 3, indicating more severe as scores were higher. Each parameter was scored for four fingers of both hands, except thumbs, and the median score value of each parameter in both hands was finally presented.	Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
Secondary	Changes of Nailfold Capillary Microscopic Findings (Disorganization of the Vascular Array)	In order to assess the severity of microangiopathies in both fingers, a semiquantitative scoring system for nailfold capillary microscopic findings was adopted. A total of six parameters (irregularly enlarged capillaries, giant capillaries, hemorrhages, loss of capillaries, disorganization of the vascular array and capillary ramifications) were measured using the semiquantitative manner on the scale ranging 0 to 3, indicating more severe as scores were higher. Each parameter was scored for four fingers of both hands, except thumbs, and the median score value of each parameter in both hands was finally presented.	Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks
Secondary	Changes of Nailfold Capillary Microscopic Findings (Capillary Ramifications)	In order to assess the severity of microangiopathies in both fingers, a semiquantitative scoring system for nailfold capillary microscopic findings was adopted. A total of six parameters (irregularly enlarged capillaries, giant capillaries, hemorrhages, loss of capillaries, disorganization of the vascular array and capillary ramifications) were measured using the semiquantitative manner on the scale ranging 0 to 3, indicating more severe as scores were higher. Each parameter was scored for four fingers of both hands, except thumbs, and the median score value of each parameter in both hands was finally presented.	Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks