Background: Autologous cell therapy (ACT) is the last option for patients with no-option chronic limb-threatening ischemia (NO-CLTI) and severe pain. The aim of our study was to assess the impact of ACT on a patient’s quality of life, chronic pain and depression using standardized questionnaires.

Methods: Forty patients with NO-CLTI were randomized and divided into groups treated initially with ACT (iACT, n=20) or standard conservative therapy (iST, n=16); 4 patients dropped out of the study. After 3 months, those in the standard therapy (ST) group were switched to (cell therapy crossover). All patients filled out the standardized EQ-5D questionnaire assessing their quality of life. Pain was evaluated using a special questionnaire including the Visual Analogue Scale (VAS) and Wong-Baker Faces (WB). The questionnaires were evaluated before randomization; in the iST group at 3 months after ST and then at 3 months after ACT.

Results: Pain was significantly reduced in the iACT group after 3 months compared to baseline in both VAS and WB scores (both p<0.001); in the iST group, we observed even worsening of both pain scores without a significant difference (NS). After the cell therapy crossover of in the iST group, both pain scores increased significantly after 3 months (both p<0.001). Quality of life measured by EQ-5D was improved after 3 months of ACT (p<0.001) while not changing in the iST group after 3 months of ST (NS). After the crossover to ACT, quality of life was significantly improved also in the iST group (p<0.001). We observed a trend in towards a decrease in depression rate after 3 months of iACT from 45 to 33%, whereas the depression rate was slightly increased after 3 months of ST (from 56 to 61%) to decrease from 56 to 18% in the iST group after cell therapy crossover (all NS).

Conclusion: Our study showed significant pain reduction in NO-CLTI patients after ACT; this treatment also led to a decrease in depression rate and overall improvement in their quality of life.

Disclosure

J. Husáková: None. R. Bem: None. A. Nemcova: None. V. Fejfarova: None. A. Jirkovska: None. M. Dubsky: None.

Funding

Ministry of Health of the Czech Republic (16-27262A); Project for Development of Research Organization (00023001); IKEM, Prague, Czech Republic

© 2020 by the American Diabetes Association
2020
Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. More information is available at http://www.diabetesjournals.org/content/license.