Systemic Sclerosis
Conditions
Keywords
Hand deformities in Systemic sclerosis
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 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.
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), 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.
Interventions
DRUGADSVF application in the right hand
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
Sponsors
National Council of Science and Technology, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Adipose Derived Stromal Vascular Fraction (ADSVF) was obtained in a laboratory by enzymatic digestion of fat graft harvested by liposuction. This ADSVF and micro fat grafts were applied into the hands with fibrosis and digital ulcers caused by Systemic Sclerosis in the experimental group. The control group was treated with medical treatment only
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 168 days | 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 |
| Frequency of Raynaud Phenomenon | 168 days | Frequency, number of events per day/week; |
| Duration of Raynaud Phenomenon | 168 days | Duration of minutes in every event. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Digital Total active Motion | 168 days | Goniometry, kapandjy Test |
| Digital oximetry | 168 days | Transcutaneous Oximetry |
| Digital Ulcers | 168 days | Number of ulcers |
| Health status and disability index | 168 days | 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 |
| Hand Function | 168 days | Cochin Scale, the values are from 0 to 90, higher values means poor function |
| Health-related quality of life, before de treatment and at the end of the study | 168 days | Short Form 36 (SF-36) scale. High values is poor patient health |
| Vascularity of the nail bed | 168 days | Videocapillaroscopy by field |
| Skin affection of the hand | 168 days | Modified Rodnan scale, the values are from 0 to 51. High values higher skin fibrosis |
Countries
Mexico
Outcome results
None listed