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.
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), were initially described in 2002. These cells have the characteristics of being multipotent and exerting local angiogenic, anti-inflammatory, antifibrotic, immunomodulatory, and regenerative effects after application. ASCs express their angiogenic properties most effectively in a hypoxic environment. For the above reasons, and because of its abundance in fat, easy acquisition, and almost immediate availability for use, ADSVF has positioned itself as an alternative for repair and regeneration of ischemic tissue. Application of decanted fat, centrifuged fat, and ADSVF, has consistently and significantly improved pain, Raynaund Phenomen, and healing of digital ulcers in the hands of patients with SS, and thus improved their quality of life. Other inconsistent benefits have also been reported, such as decreased digital circumference, improvement in digital mobility and strength, improvement in formation of new subungual capillaries, and improvement in function through evaluation of the Cochin scale. Based on the above findings, and because changes in the hands of patients with SS may arise through loss of adipocytes and defective stem cell function, we designed the present study with the aim of evaluating the safety, reproducibility, and clinical effects of application of fat micrografts enriched with ADSVF to the hands of patients affected with SS in a controlled clinical trial. The experimental and control groups each contained 10 patients diagnosed with SS according to the criteria of the American College of Rheumatology and the LeRoy-Medsger criteria. It was decided to carry out the treatment on the most affected hand of the patients, which was the right hand in the entire experimental group. ADSVF-enriched fat micrografts were applied to the experimental group. Evolution and medical therapy effects were observed in the control group. The fat was obtained by liposucction and the ADSVF was processed in laboratory.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
40 ml of fat was mixed with 2 ml of ADSVF and placed in 1-ml and 3-ml syringes. Using a 19-gauge blunt cannula (0.8 mm), 0.5 ml was applied to the radial and ulnar edge of each metacarpal phalangeal (MP) and interphalangeal (IP) joint in contact with each neurovascular digital pedicle and 3 ml was applied to each side of the metacarpal trapezius joint, together with 10 ml distributed subcutaneously throughout the palm of the hand and 10 ml evenly distributed on the back of the hand
Instituto Nacional de Ciencias Medicas y Nutricion salvador Zubiran
México, Mexico
Pain before the treatment and every day during one week after the treatment, and each 28 days after de first week until the 168 day
Evaluation with Numerical Pain Rating Scale(NPRS) before, and after the intervention. The minimum value is 0 and maximum is 10. High value is worst
Time frame: 168 days
Frequency of Raynaud Phenomenon
Frequency, number of events per day/week;
Time frame: 168 days
Duration of Raynaud Phenomenon
Duration of minutes in every event.
Time frame: 168 days
Digital Total active Motion
Goniometry, kapandjy Test
Time frame: 168 days
Digital oximetry
Transcutaneous Oximetry
Time frame: 168 days
Digital Ulcers
Number of ulcers
Time frame: 168 days
Health status and disability index
Evaluated by Sclerosis Health assessment Questionnarie (SHAQ) scale, before and at the end of the study. The value are from 0 to 3. A result \>1.25 is worst
Time frame: 168 days
Hand Function
Cochin Scale, the values are from 0 to 90, higher values means poor function
Time frame: 168 days
Health-related quality of life, before de treatment and at the end of the study
Short Form 36 (SF-36) scale. High values is poor patient health
Time frame: 168 days
Vascularity of the nail bed
Videocapillaroscopy by field
Time frame: 168 days
Skin affection of the hand
Modified Rodnan scale, the values are from 0 to 51. High values higher skin fibrosis
Time frame: 168 days
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