Safety Of Fat Micrografts With Adipose-Derived Stromal Vascular Fraction In Hands Of Patients With Systemic Sclerosis

• Status: Completed
• Trial end date: 2020-05-01
• Target enrollment: 0
• Participant gender: All

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 decrease patient quality of life.

Local application of adipose-derived stromal vascular fraction (ADSVF) has been proposed as an emerging treatment. There are reports about the good results obtained after ADSVF treatment in this kind of patients. For these reasons , we aimed to evaluate the safety and clinical effect of application of fat micrografts enriched with ADSVF to the hands of patients with SS.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Collaborator: National Council of Science and Technology, Mexico

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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