Status:
COMPLETED
Safety Of Fat Micrografts With Adipose-Derived Stromal Vascular Fraction In Hands Of Patients With Systemic Sclerosis
Lead Sponsor:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Collaborating Sponsors:
National Council of Science and Technology, Mexico
Conditions:
Systemic Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Systemic sclerosis (SS) causes microvascular alteration in the hand and subsequently pain, skin fibrosis, and osteoarticular deformities. These injuries initiate functional decline of the hand and dec...
Detailed Description
The regenerative properties of adipose stem cells (ASCs) existing in the mixed cell fraction obtained by enzymatic digestion of adipose tissue, termed adipose-derived stromal vascular fraction (ADSVF)...
Eligibility Criteria
Inclusion
- Patients diagnosed with SS, according to the criteria of the American College of Rheumatology and those of LeRoy-Medsger.
- Over 18 years old,
- BMI\> 18 kg / m2.
- Patients received stable vasoactive and immunosuppressive therapies, for at least 1 month before being enrolled in the study, and this was continued unchanged throughout the study.
Exclusion
- infected digital ulcers
- comorbidities that could affect hand function
- alcoholism
- drug abuse
- history of family cancer
- Patients with hyperbaric therapy one month before
- Botulinum toxin one month before
- surgical sympathectomy one month before
Key Trial Info
Start Date :
August 13 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04387825
Start Date
August 13 2015
End Date
May 1 2020
Last Update
May 15 2020
Active Locations (1)
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1
Instituto Nacional de Ciencias Medicas y Nutricion salvador Zubiran
México, Mexico, 14080