Cell-based therapy, including the use of stem cell therapy, offers considerable hope for patients with end-stage liver cell failure [9, 10]. We report a prospective cohort study using a quality-of-life survey, SF-36 v2, conducted on 50 posthepatitis C virus cirrhosis patients receiving stem cell therapy at our center, to be compared with the survey results conducted on a group of posthepatitis C virus cirrhosis patients (n = 50), receiving the standard line of care, and a group of healthy blood donors (n = 50).
The overall compliance rate for survey completion in our study was high (98%). This rate reflects our policy of monitoring all patients who received stem cell therapy for 1 year at our center and administering the surveys, in person, at those scheduled visits. This policy differs from other quality-of-life reports used in similar studies in liver transplantation patients [11, 12], but we believe that this approach provides maximum information regarding the impact of stem cell therapy on cirrhosis patients at various time points.
Our study was conducted in a nonprofit governmental hospital where the patients are of low socioeconomic status; this fact may influence their HRQoL scores and the results of our study as well, which may differ from those with patients attending a private hospital in Egypt.
The pretherapy SF-36 v2 scores of patients in SCT group (I) were significantly below average as compared with those of the healthy control subjects. This is an expected finding because they are patients with end-stage liver disease. In comparison of their scores with those of patients in the SMT group (II), we found that PCS, GH, BP, VT, and MH scores show no statistically significant difference between the groups, but PF is significantly greater in the SCT group (I), whereas MCS, RE, SF, and RP are significantly greater in the SMT group (II).
Our patients found the overall stem cell therapy process positive; this was reported through the consistent improvement of the patients' PCS and MCS scores in all patients until the end of the first year of follow-up to reach the average values of the healthy volunteers, indicating that stem cell therapy improves the HRQoL. Most of the SF-36 eight domains (PF, RP, SF, RE, GH, and VT) showed consistent improvement during the follow-up period in all patients back to pretherapy; this accords with reports by other studies [13, 14].
Regarding the laboratory data of patients in SCT group (I), it was noticed that platelets and WBCs (white blood cells) counts did not show any statistically significant change during the follow-up period, but a significant reduction in hemoglobin and albumin levels occurred in the first month of follow-up; hemoglobin reached a steady level until the end of the follow-up period, whereas albumin showed a significant increase by the third month of follow-up, but it decreased significantly again to reach a steady value until the end of the follow-up period. This result coincides with those of some published studies [5, 6], but does not agree with other published studies [10, 14, 15].
INR values continued to decrease significantly until the third month of follow-up, but a marked significant increase was observed by the end of the first year of follow-up, which agrees with what was concluded by Lyra et al. .
The total serum bilirubin levels continue to decrease up to the sixth month of follow-up. Then they show a significant increase by the end of the first year of follow-up, but significantly less than its pretherapy level. These findings are consistent with the results of other studies [5, 8, 10, 14, 16, 17].
For the liver enzymes, both AST and ALT levels showed statistically significant changes during the period of follow-up; at the first month after therapy, they decreased, then increased by the third month, and then decreased again by the sixth month, to increase by the end of the first year of follow-up. It worth mentioning that the significant change in the biochemical profile and the ascites grade in the SCT group (I) had markedly decreased the need for receiving the standard line of care for such patients, so the patients were managed accordingly.
In the SCT group (I), in comparing the change in the clinical findings with changes in the quality of life, we noticed that at 1 month, the quality of life scores was improved together with laboratory results; this agrees with that reported by Kondo et al. . However, the liver enzymes deteriorated after being improved after 3 months, and the total bilirubin increased again after 6 months, while all the quality-of-life domains continued to improve, except for the BP and MH, which remained almost constant after the first month. This is significantly less than those of the normal healthy subjects, which means that the quality-of-life domains are not affected by the changes in the liver function, except in the early stage after stem cell therapy, which does not agree with results reported by El Garem et al. . This may be attributed to the difference in the technique used for stem cell therapy; El Garem injected 5 to 10 million cells in 10 ml under sonographic guidance into the spleens of his patients.
Our result might be explained by the hypothesis that the bodily pain subscale is a two-item scale that measures perception of pain and how much pain interferes with normal work, including both outdoor work and housework, where the score does not continue to improve after the first month and becomes constant. This may be due to mild significant elevation of liver enzymes after the first month; moreover, some patients develop mild to moderate ascites, which leads to abdominal pain in some patients.
Conversely, the mental health subscale is a five-item scale that measures nervousness, happiness, depression, peacefulness, and feeling so down-in-the-dumps. Its score does not continue to increase after the first month, and that may be attributed to the depression and the nervousness that the end-stage liver disease patients experience and directly affects their work; their activity become much less than usual.
The SF-36 v2 is a subjective health survey; our results showed that no close association occurs between subjective and objective data such as liver-function tests, except in the early post-stem therapy phase. These observation agree with those of Kondo et al. , but on following up our patients, the issue becomes different, and this may be because no follow-up data were acquired in the Kondo study; moreover, this is also attributed to the difference in the studied groups. In Kondo et al. , the study group was hepatocellular carcinoma patients. Conversely, some significant relations between the SF-36 v2 domain scores and laboratory data were detected in our studied group of patients. A relation exists between SF-36 v2 domains after 1 year of therapy; PCS, MCS, and RP with AST after 3 months of therapy; ALT before therapy, and ALT after 1 month of therapy, respectively. A relation exists between the laboratory data before therapy and AST, ALT, and total bilirubin and MCS after 6 months, PCS after 3 months, and RP after 1 year of therapy.
After 1 year of follow-up of both SCT and SMT group, mortality was reported in three cases (6%) of the SCT group (I), whereas 19 (38%) cases of the SMT group (II), with a statistically significant difference between the mean survival times of both groups and no malignancy cases reported in the SCT group (I) after treatment all through the follow-up period. This difference agrees with what was reported in Nouman et al. , but with lower mortality rates in the stem cell-treated group of patients.
This study suggests that the SCT patient finds the overall experience to be a positive one. The study also allowed us to critically examine the various aspects of our patient-evaluation process and to develop recommendations for future use. Some of the major suggestions derived from this study are as follows: (a) It should be stressed that significant postoperative pain will occur, but it can be controlled; (2) follow-up at an SCT clinic should be provided for a 1-year period, when possible, to allow the detection of late-occurring complications related to therapy that may go unrecognized in other settings; and (c) donors should be provided with a realistic assessment of what the SCT outcome is likely to be.
A potential weakness in our method of evaluating SCT recipient quality of life is that a member of the SCT team had conducted the surveys by himself. This approach clearly results in a high rate of survey compliance, but it may also deter some patients from answering sensitive questions truthfully, as a clear association between the respondent and answer by the physician is possible. Currently, we are considering providing the donors each with a short questionnaire and a stamped, self-addressed envelope. They will be asked to complete the survey and return it anonymously.
The results of our study showed no influence of diabetes mellitus on the HRQoL scores of patients who were subjected to SCT before therapy or after therapy during the period of follow-up, where the SF-36 v2 domains scores are insignificantly different in diabetic patients than those with no diabetes. This does not agree with the concept represented in 2000 by William H. Polonsky . This may be explained because the diabetes patients in our study were well controlled with either insulin or oral hypoglycemic drugs; moreover, no diabetic complications were encountered in our studied group.