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Mast Cell Activation Test in Allergic Disease
trial in Asthma in 19 participants. Completed in 1 December 2019.
| Lead sponsor | Hong Kong Sanatorium & Hospital |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 19 |
| Start date | 1 February 2018 |
| Primary completion | 1 December 2019 |
| Estimated completion | 1 December 2019 |
| Sites | 1 location across Hong Kong |
Hong Kong Sanatorium & Hospital — full company profile →
18 and older, any sex, with Asthma or Mastocytosis. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Mast Cell Activation Test results of high/low level of house dust mite sensitivity by using normal donor cultured mast cells for validation.
| Group | Value | 95% CI |
|---|---|---|
| Validation Group | 6 | |
| Validation Group | 2 |
| Group | Value | 95% CI |
|---|---|---|
| Validation Group | 0 | |
| Validation Group | 4 |
Patient's serum was incubated with mast cells derived from normal donors for detection of mast cell activation as evidenced by histamine release.
| Group | Value | 95% CI |
|---|---|---|
| Validation Group | 0 | |
| SH#1 | 1 | |
| SH#2 | 0 | |
| SH#3 | 0 | |
| SH#4 | 0 | |
| SH#5 | 0 | |
| SH#6 | 0 | |
| SH#7 | 0 |
percentage of total histamine release by normal average responder mast cells that had been activated with patient's serum
| Group | Value | 95% CI |
|---|---|---|
| Validation Group | 2.15 | ± 0.71 |
| SH#1 | 32.1 | |
| SH#2 | 3.3 | |
| SH#3 | 2.8 | |
| SH#4 | 3.4 | |
| SH#5 | 5.1 | |
| SH#6 | 3.2 | |
| SH#7 | 3.8 |
percentage of total histamine release by patient's mast cells that had been activated with anti-IgE
| Group | Value | 95% CI |
|---|---|---|
| SH#1 | 11.5 | |
| SH#2 | 38.3 | |
| SH#3 | 69.6 | |
| SH#4 | 47.9 | |
| SH#5 | 36.3 | |
| SH#6 | 45.5 | |
| SH#7 | 41.6 |
Percentage of total histamine release when patient's mast cells were activated with patient's own serum and Der p2. Each patient's results are reported individually.
| Group | Value | 95% CI |
|---|---|---|
| SH#1 | 24.5 | |
| SH#2 | 54.7 | |
| SH#3 | 79 | |
| SH#4 | 8.4 | |
| SH#5 | 0.2 | |
| SH#6 | 0.2 | |
| SH#7 | 0 |
Cell yield of patient's mast cell culture after 9 weeks in culture as an index of cell growth and differentiation.
| Group | Value | 95% CI |
|---|---|---|
| SH#1 | 14045000 | |
| SH#2 | 2895522 | |
| SH#3 | 115294 | |
| SH#4 | 625263 | |
| SH#5 | 4867778 | |
| SH#6 | 352000 | |
| SH#7 | 1400000 |
Activation of mast cells in the immune system is known to cause allergic reactions sometimes with severe systemic symptoms. The investigators have recently developed a blood-based mast cell activation diagnostic test in which levels of functional activation in-vitro in primary cultured mast cells generated from the peripheral blood of single individuals can be assessed. It is the hypothesis that the test can be used to predict the potential state of in-vivo mast cell activation in any individual based on the functional activation profiles exhibited by their cultured mast cells. The investigators now wish to translate their in-vitro findings in a pilot study to disease groups where mast cell activation is expected to be high. These include highly allergic individuals; those with chronic idiopathic urticaria; those with mastocytosis; and those with the mast cell activation syndrome. Furthermore, they will use the functional genomics approach to identify gene expression biomarkers that are correlated with such diseases. The results will be compared with data that have been collected from a cohort of healthy control blood donors.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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