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.


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


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

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