Discussion
fibrous, pain, hand complications, Raynaud’s phenomenon, SSc
RECURRENCE, ULCERS, BLIND, DIGITAL ULCERS
The application of decanted fat [In controlled studies comparing the utility of ADSVF vs. placebo, the authors reported no statistically significant changes in Cochin Functional Scale Score, between the two groups [Prior to the authorization of this protocol, we treated two patients with SSc and severe pain with 1.5 cc micrografts of decanted fat applied along each digital neuro-vascular pedicle. They presented a significant decrease in pain. We cannot explain the reason for the decrease in pain, but it may be that the simple distension of the fibrous tissue around the nerves caused the pain to decrease. Perhaps these changes are similar to those observed by Daumas [Despite the different results in all these clinical studies, there is a statistical trend that the application of ADSVF may be useful for the treatment of hand complications caused by SSc.The present controlled study with a 6-month follow-up period included patients with diffuse and limited SSc as well as moderate vascular and articular involvement, including some with severe internal organ involvement. The results observed in the experimental group were similar to those reported in uncontrolled studies. However, when the variables were compared with those of the control group, only the improvement in pain and number of digital ulcers were statistically significant. Only Raynaud’s phenomenon and the quality of the skin on the hands improved significantly in the control group patients. We consider that these changes in the control group were due to medical treatment, rehabilitation, and the change in temperature to a warmer environment when the final evaluation of the study was carried out.We apply fat micrografts with the aim of giving volume to the sclerotic fingers of patients with SSc. This volumetric effect of fat grafting has been well demonstrated [The mixture of fat micrografts plus ADSVF has previously been used in plastic surgery with the aim of increasing the integration of fat grafts. This procedure has been called cell-assisted lipotransfer [The treated hands of the experimental group patients exhibited a clinically greater volume, warmer temperatures, and faster capillary filling than the contralateral hands of the same patients and hands of the control group patients. Although these variables were not planned to be evaluated, they were clinical findings that we consider important to mention. This greater volume could prevent the recurrence of ulcers on the bony prominences.The site and technique used for acquiring the lipoaspirate affect the quality of the ADSVF in terms of its use for regenerative treatment [In this study, we isolated the ADSVF in a cell biology laboratory. The mean number of viable cells was three times higher compared to those processed by a closed system kit (Celution 800/CRS system and SmartXR kit o DongKoo Bio & Pharma Co., Ltd., South Korea) [The techniques performed by the Granel and Magalon group for the characterization and determination of the proportion of the ASCs contained in the ADSVF were consistent with the requirements of the International Federation for Adipose Therapeutics and Science and the International Society for Cellular Therapy and with the Bourin report [It has been demonstrated that the vascular or regenerative properties of the ADSVF are not compromised by SSc [We must point out that this study was carried out exclusively in Mexican mestizo patients and despite this, the results are similar to those previously reported. However, it is important to mention that in future studies ethnicity should be a variable to consider.This study has the disadvantages of not having been a blind study for patients and researchers, as well as a limited number of patients studied. Although the number of digital ulcers was statistically lower in the experimental group compared to the control group at the end of the study, these results must be interpreted with caution, since unfortunately we did not assess the number of digital ulcers existing at the beginning and at the end of the study in each patient. The loss of a patient even though he belonged to the control group is a significant loss considering the size of the sample. Future studies should try to avoid these limitations.