Clinical Study of Allergic Rhinitis Therapy by Stem Cells
Primary Purpose
Allergic Rhinitis
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Low dose UCMSCs
Moderate dose UCMSCs
High dose UCMSCs
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Rhinitis focused on measuring Umbilical cord, Mesenchymal Stem Cells, Allergic Rhinitis, Therapy
Eligibility Criteria
Inclusion Criteria:
- Patients with moderate to severe persistent allergic rhinitis who meet the diagnostic criteria for allergic rhinitis (2015 Tianjin standard);
- The results of allergen examination showed that the allergen was a single allergy of dust mite;
- After more than 2 years of antihistamine, nasal glucocorticoid and other drug treatments, the curative effect is poor, and the symptoms seriously affect the patient's life;
- Age 18-60 years old;
- The patient refused to receive allergen-specific immunotherapy;
- The patient is willing to receive stem cell therapy and sign an informed consent.
Exclusion Criteria:
- The subject is accompanied by sinusitis, asthma and aspirin intolerance;
- The subjects suffer from severe primary heart, liver, lung, kidney and blood diseases;
- The subjects suffer from Malignant tumors;
- The subjects suffer from severe immune diseases;
- The subjects suffer from mental illness;
- Female subjects who are or are about to become pregnant, pregnant or breastfeeding;
- Patients who are participating in other clinical trials;
- In addition to the above conditions, there are other reasons why researchers believe that they are not suitable to participate in this clinical study.
Sites / Locations
- Yantai Yuhuangding HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Low dose UCMSCs
Moderate dose UCMSCs
High dose UCMSCs
Arm Description
Outcomes
Primary Outcome Measures
Severity and incidence of adverse events (SIAE) on the day of treatment
The assessment was conducted according to the Common Adverse Event Evaluation Standard 4.0 (NCI-CTCAE v4.0) jointly issued by the U.S. Department of Health and Human Services, the National Institutes of Health, and the National Cancer Institute.
3rd day SIAE
The assessment was conducted according to the Common Adverse Event Evaluation Standard 4.0 (NCI-CTCAE v4.0) jointly issued by the U.S. Department of Health and Human Services, the National Institutes of Health, and the National Cancer Institute.
1 week SIAE
The assessment was conducted according to the Common Adverse Event Evaluation Standard 4.0 (NCI-CTCAE v4.0) jointly issued by the U.S. Department of Health and Human Services, the National Institutes of Health, and the National Cancer Institute.
1 month SIAE
The assessment was conducted according to the Common Adverse Event Evaluation Standard 4.0 (NCI-CTCAE v4.0) jointly issued by the U.S. Department of Health and Human Services, the National Institutes of Health, and the National Cancer Institute.
3 months SIAE
The assessment was conducted according to the Common Adverse Event Evaluation Standard 4.0 (NCI-CTCAE v4.0) jointly issued by the U.S. Department of Health and Human Services, the National Institutes of Health, and the National Cancer Institute.
6 months SIAE
The assessment was conducted according to the Common Adverse Event Evaluation Standard 4.0 (NCI-CTCAE v4.0) jointly issued by the U.S. Department of Health and Human Services, the National Institutes of Health, and the National Cancer Institute.
12 months SIAE
The assessment was conducted according to the Common Adverse Event Evaluation Standard 4.0 (NCI-CTCAE v4.0) jointly issued by the U.S. Department of Health and Human Services, the National Institutes of Health, and the National Cancer Institute.
24 months SIAE
The assessment was conducted according to the Common Adverse Event Evaluation Standard 4.0 (NCI-CTCAE v4.0) jointly issued by the U.S. Department of Health and Human Services, the National Institutes of Health, and the National Cancer Institute.
Secondary Outcome Measures
RQLQ score
The assessment of Rhinoconjunctivitis quality of life questionnaire (RQLQ) includes daily activities, sleep, non-rhino-conjunctivitis symptoms, rhinitis-related behaviors, nasal symptoms, eye symptoms, and emotional reactions.
Each of the above aspect is composed of several measurements. A total of 28 measurements are individually scored from 0 to 6 points. A score of 0 indicates that the subject has not been affected by nose and eye symptoms in the past week, a score of 1 indicates that it is almost unaffected, a score of 2 indicates a minor influence, a score of 3 indicates a slight influence, a score of 4 indicates a moderate influence, and a score of 5 indicates a severe influence, a score of 6 indicates that it is extremely severely affected. In terms of daily activities, a score of 9 directly indicates that daily activity cannot be carried out due to nose and eye symptoms.
VAS score
Visual analogue scale (VAS) is used to evaluate the severity of nasal symptoms by patients or their guardians. Visual line marks are made on the scale with a length of 10 cm. The VAS score is calculated as 0 is asymptomatic (0 cm), and 10 is the most serious symptom (10 cm).
Nasal function test
Nasal expiratory nitric oxide (NO) test (NNO test), is a simple, noninvasive and convenient medical detection method, that can be used for the diagnosis, treatment and monitoring of nasal diseases such as rhinitis, sinusitis and nasal polyps.
Nasal endoscopy
The normal nasal mucosa is light red, with smooth, moist and shiny surface. The nasal cavity and nasopharyngeal mucosa have no congestion, edema, dryness, ulcers, hemorrhage, vasodilatation and new organisms; no purulent secretions.
The mucosa of allergic rhinitis is pale, edematous or lavender, and the discharge is watery.
U-HCG
The U-HCG test detects levels of hCG in the urine, positive result indicate pregnacy.
Detection of Serum Interferon γ (IFN-γ)
To test level of inflammatory factor Interferon γ (IFN-γ) in the serum;
Detection of Serum Interferon α (IFN-α)
To test level of inflammatory factor Interferon α (IFN-α) in the serum;
Detection of Serum Interleukin 1β (IL-1β)
To test level of inflammatory factor Interleukin 1β (IL-1β) in the serum;
Detection of Serum Interleukin 2 (IL-2)
To test level of inflammatory factor Interleukin 2 (IL-2) in the serum;
Detection of Serum Interleukin 4 (IL-4)
To test level of inflammatory factor Interleukin 4 (IL-4) in the serum;
Detection of Serum Interleukin 5 (IL-5)
To test level of inflammatory factor Interleukin 5 (IL-5) in the serum;
Detection of Serum Interleukin 6 (IL-6)
To test level of inflammatory factor Interleukin 6 (IL-6) in the serum;
Detection of Serum Interleukin 8 (IL-8)
To test level of inflammatory factor Interleukin 8 (IL-8) in the serum;
Detection of Serum Interleukin 10 (IL-10)
To test level of inflammatory factor Interleukin 10 (IL-10) in the serum;
Detection of Serum Interleukin 12P70 (IL-12P70)
To test level of inflammatory factor Interleukin 12P70 (IL-12P70) in the serum;
Detection of Serum Interleukin 17A (IL-17A)
To test level of inflammatory factor Interleukin 17A (IL-17A) in the serum;
Detection of Serum Tumor necrosis factor-α(TNF-α)
To test level of inflammatory factor Tumor necrosis factor-α(TNF-α) in the serum;
Detection of inflammatory factor Interferon γ (IFN-γ) in nasal secretions
To test level of inflammatory factor Interferon γ (IFN-γ) in nasal secretions;
Detection of inflammatory factor Interferon α (IFN-α) in nasal secretions
To test level of inflammatory factor Interferon α (IFN-α) in nasal secretions;
Detection of inflammatory factor Interleukin 1β (IL-1β) in nasal secretions
To test level of inflammatory factor Interferon α (IFN-α) in nasal secretions;
Detection of inflammatory factor Interleukin 2 (IL-2) in nasal secretions
To test level of inflammatory factor Interleukin 2 (IL-2) in nasal secretions;
Detection of inflammatory factor Interleukin 4 (IL-4) in nasal secretions
To test level of inflammatory factor Interleukin 4 (IL-4) in nasal secretions;
Detection of inflammatory factor Interleukin 5 (IL-5) in nasal secretions
To test level of inflammatory factor Interleukin 5 (IL-5) in nasal secretions;
Detection of inflammatory factor Interleukin 6 (IL-6) in nasal secretions
To test level of inflammatory factor Interleukin 6 (IL-6) in nasal secretions;
Detection of inflammatory factor Interleukin 8 (IL-8) in nasal secretions
To test level of inflammatory factor Interleukin 8 (IL-8) in nasal secretions;
Detection of inflammatory factor Interleukin 10 (IL-10) in nasal secretions
To test level of inflammatory factor Interleukin 10 (IL-10) in nasal secretions;
Detection of inflammatory factor Interleukin 12P70 (IL-12P70) in nasal secretions
To test level of inflammatory factor Interleukin 12P70 (IL-12P70) in nasal secretions;
Detection of inflammatory factor Interleukin 17A (IL-17A) in nasal secretions
To test level of inflammatory factor Interleukin 17A (IL-17A) in nasal secretions;
Detection of inflammatory factor Tumor necrosis factor-α(TNF-α) in nasal secretions
To test level of inflammatory factor Tumor necrosis factor-α(TNF-α) in nasal secretions;
Full Information
NCT ID
NCT05151133
First Posted
November 10, 2021
Last Updated
March 26, 2023
Sponsor
Yantai Yuhuangding Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05151133
Brief Title
Clinical Study of Allergic Rhinitis Therapy by Stem Cells
Official Title
Clinical Study of Moderate to Severe Persistent Allergic Rhinitis Therapy by Human Umbilical Cord Mesenchymal Stem Cells
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 13, 2022 (Actual)
Primary Completion Date
December 15, 2024 (Anticipated)
Study Completion Date
December 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yantai Yuhuangding Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators is now carrying out a clinical study of Umbilical cord Mesenchymal Stem Cells (UCMSCs) in the treatment of Allergic rhinitis (AR). UCMSCs is known to its multilineage differentiation potential, strong proliferation ability, low immunogenicity, convenient material acquisition, and fewer restrictions on ethical and moral issues. The investigators hope to find a novel, minimally invasive, effective and simple treatment for the large number of patients with persistent moderate to severe AR.
Detailed Description
Allergic rhinitis (AR), is a noninfectious inflammatory disease of nasal mucosa mediated by immunoglobulin E (IgE) antibody and involved in a variety of immune active cells and cytokines after the atopic body is exposed to allergens. The incidence of allergic rhinitis increases as people's living standards improves. It is estimated that about 1.4 billion people worldwide have been affected by the disease. Some patients with moderate to severe AR have no improvement in symptoms after drug treatment, which continues to affect daily life and work. Therefore, these patients urgently needs a new, minimally invasive, effective and simple treatment. Mesenchymal Stem Cells (MSCs) are pluripotent stem cells derived from the mesoderm, which can differentiate into bone, cartilage, fat and other cells. MSCs can also secrete a variety of bioactive molecules, which have the effects of regulating immunity and anti-inflammatory. Based on its immunomodulatory effect, MSCs is gradually becoming a new star in the treatment of allergic diseases. In pre-clinical studies on the treatment of AR, MSCs have shown good therapeutic effect in the treatment of allergic rhinitis.
This study is a prospective, open, single-center clinical study. Participants were recruited into three different dose groups. The cohort size of each dose group was 6 participants. The subjects of each group each will receive one course of treatment with a single injection. Subjects of group 1 will receive 0.5×10^6 cells/kg, with a total volume of 100 ml UCMSCs; group 2 will receive 1.0×10^6 cells/kg; with a total volume of 100 ml UCMSCs; group 3 will receive 2.0×10^6 cells/kg, with a total volume of 100 ml UCMSCs. One month after each injection, the Data and Safety Monitoring Committee (DSMC) will comprehensively evaluate the results of the phased clinical research, and after determining the safety and feasibility of the research, the enrollment of the next phase will start. The subjects will be followed up on the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment. The main outcome measures are the severity and incidence of adverse events. The secondary outcome measures are RQLQ score, VAS score, serum inflammatory factor detection, nasal secretion inflammatory factor detection, nasal function test and nasal endoscopy, etc. In addition, the investigators will also monitor safety indicators such as blood routine, urine routine, liver and kidney function, immunological indicators, tumor markers, etc. At the end of the study, according to the data obtained, the clinical safety and feasibility of intravenous infusion of UCMSCs in the treatment of moderate to severe persistent AR will be evaluated, so as to provide drug dose basis for the next stage of clinical research.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis
Keywords
Umbilical cord, Mesenchymal Stem Cells, Allergic Rhinitis, Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Low dose UCMSCs
Arm Type
Experimental
Arm Title
Moderate dose UCMSCs
Arm Type
Experimental
Arm Title
High dose UCMSCs
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Low dose UCMSCs
Intervention Description
Receive one course of treatment with a single injection : 0.5×10^6 cells/kg, with a total volume of 100 ml UCMSCs;
Intervention Type
Biological
Intervention Name(s)
Moderate dose UCMSCs
Intervention Description
Receive one course of treatment with a single injection : 1.0×10^6 cells/kg, with a total volume of 100 ml UCMSCs;
Intervention Type
Biological
Intervention Name(s)
High dose UCMSCs
Intervention Description
Receive one course of treatment with a single injection : 2.0×10^6 cells/kg, with a total volume of 100 ml UCMSCs;
Primary Outcome Measure Information:
Title
Severity and incidence of adverse events (SIAE) on the day of treatment
Description
The assessment was conducted according to the Common Adverse Event Evaluation Standard 4.0 (NCI-CTCAE v4.0) jointly issued by the U.S. Department of Health and Human Services, the National Institutes of Health, and the National Cancer Institute.
Time Frame
Day 1 of treatment
Title
3rd day SIAE
Description
The assessment was conducted according to the Common Adverse Event Evaluation Standard 4.0 (NCI-CTCAE v4.0) jointly issued by the U.S. Department of Health and Human Services, the National Institutes of Health, and the National Cancer Institute.
Time Frame
3 days after treatment
Title
1 week SIAE
Description
The assessment was conducted according to the Common Adverse Event Evaluation Standard 4.0 (NCI-CTCAE v4.0) jointly issued by the U.S. Department of Health and Human Services, the National Institutes of Health, and the National Cancer Institute.
Time Frame
1 week after treatment
Title
1 month SIAE
Description
The assessment was conducted according to the Common Adverse Event Evaluation Standard 4.0 (NCI-CTCAE v4.0) jointly issued by the U.S. Department of Health and Human Services, the National Institutes of Health, and the National Cancer Institute.
Time Frame
1 month after treatment
Title
3 months SIAE
Description
The assessment was conducted according to the Common Adverse Event Evaluation Standard 4.0 (NCI-CTCAE v4.0) jointly issued by the U.S. Department of Health and Human Services, the National Institutes of Health, and the National Cancer Institute.
Time Frame
3 months after treatment
Title
6 months SIAE
Description
The assessment was conducted according to the Common Adverse Event Evaluation Standard 4.0 (NCI-CTCAE v4.0) jointly issued by the U.S. Department of Health and Human Services, the National Institutes of Health, and the National Cancer Institute.
Time Frame
6 months after treatment
Title
12 months SIAE
Description
The assessment was conducted according to the Common Adverse Event Evaluation Standard 4.0 (NCI-CTCAE v4.0) jointly issued by the U.S. Department of Health and Human Services, the National Institutes of Health, and the National Cancer Institute.
Time Frame
12 months after treatment
Title
24 months SIAE
Description
The assessment was conducted according to the Common Adverse Event Evaluation Standard 4.0 (NCI-CTCAE v4.0) jointly issued by the U.S. Department of Health and Human Services, the National Institutes of Health, and the National Cancer Institute.
Time Frame
24 months after treatment
Secondary Outcome Measure Information:
Title
RQLQ score
Description
The assessment of Rhinoconjunctivitis quality of life questionnaire (RQLQ) includes daily activities, sleep, non-rhino-conjunctivitis symptoms, rhinitis-related behaviors, nasal symptoms, eye symptoms, and emotional reactions.
Each of the above aspect is composed of several measurements. A total of 28 measurements are individually scored from 0 to 6 points. A score of 0 indicates that the subject has not been affected by nose and eye symptoms in the past week, a score of 1 indicates that it is almost unaffected, a score of 2 indicates a minor influence, a score of 3 indicates a slight influence, a score of 4 indicates a moderate influence, and a score of 5 indicates a severe influence, a score of 6 indicates that it is extremely severely affected. In terms of daily activities, a score of 9 directly indicates that daily activity cannot be carried out due to nose and eye symptoms.
Time Frame
The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Title
VAS score
Description
Visual analogue scale (VAS) is used to evaluate the severity of nasal symptoms by patients or their guardians. Visual line marks are made on the scale with a length of 10 cm. The VAS score is calculated as 0 is asymptomatic (0 cm), and 10 is the most serious symptom (10 cm).
Time Frame
The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Title
Nasal function test
Description
Nasal expiratory nitric oxide (NO) test (NNO test), is a simple, noninvasive and convenient medical detection method, that can be used for the diagnosis, treatment and monitoring of nasal diseases such as rhinitis, sinusitis and nasal polyps.
Time Frame
The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Title
Nasal endoscopy
Description
The normal nasal mucosa is light red, with smooth, moist and shiny surface. The nasal cavity and nasopharyngeal mucosa have no congestion, edema, dryness, ulcers, hemorrhage, vasodilatation and new organisms; no purulent secretions.
The mucosa of allergic rhinitis is pale, edematous or lavender, and the discharge is watery.
Time Frame
The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Title
U-HCG
Description
The U-HCG test detects levels of hCG in the urine, positive result indicate pregnacy.
Time Frame
The day of enrollment screening, 3 months, 6 months, 12 months, and 24 months after the treatment.
Title
Detection of Serum Interferon γ (IFN-γ)
Description
To test level of inflammatory factor Interferon γ (IFN-γ) in the serum;
Time Frame
The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Title
Detection of Serum Interferon α (IFN-α)
Description
To test level of inflammatory factor Interferon α (IFN-α) in the serum;
Time Frame
The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Title
Detection of Serum Interleukin 1β (IL-1β)
Description
To test level of inflammatory factor Interleukin 1β (IL-1β) in the serum;
Time Frame
The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Title
Detection of Serum Interleukin 2 (IL-2)
Description
To test level of inflammatory factor Interleukin 2 (IL-2) in the serum;
Time Frame
The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Title
Detection of Serum Interleukin 4 (IL-4)
Description
To test level of inflammatory factor Interleukin 4 (IL-4) in the serum;
Time Frame
The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Title
Detection of Serum Interleukin 5 (IL-5)
Description
To test level of inflammatory factor Interleukin 5 (IL-5) in the serum;
Time Frame
The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Title
Detection of Serum Interleukin 6 (IL-6)
Description
To test level of inflammatory factor Interleukin 6 (IL-6) in the serum;
Time Frame
The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Title
Detection of Serum Interleukin 8 (IL-8)
Description
To test level of inflammatory factor Interleukin 8 (IL-8) in the serum;
Time Frame
The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Title
Detection of Serum Interleukin 10 (IL-10)
Description
To test level of inflammatory factor Interleukin 10 (IL-10) in the serum;
Time Frame
The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Title
Detection of Serum Interleukin 12P70 (IL-12P70)
Description
To test level of inflammatory factor Interleukin 12P70 (IL-12P70) in the serum;
Time Frame
The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Title
Detection of Serum Interleukin 17A (IL-17A)
Description
To test level of inflammatory factor Interleukin 17A (IL-17A) in the serum;
Time Frame
The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Title
Detection of Serum Tumor necrosis factor-α(TNF-α)
Description
To test level of inflammatory factor Tumor necrosis factor-α(TNF-α) in the serum;
Time Frame
The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Title
Detection of inflammatory factor Interferon γ (IFN-γ) in nasal secretions
Description
To test level of inflammatory factor Interferon γ (IFN-γ) in nasal secretions;
Time Frame
The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Title
Detection of inflammatory factor Interferon α (IFN-α) in nasal secretions
Description
To test level of inflammatory factor Interferon α (IFN-α) in nasal secretions;
Time Frame
The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Title
Detection of inflammatory factor Interleukin 1β (IL-1β) in nasal secretions
Description
To test level of inflammatory factor Interferon α (IFN-α) in nasal secretions;
Time Frame
The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Title
Detection of inflammatory factor Interleukin 2 (IL-2) in nasal secretions
Description
To test level of inflammatory factor Interleukin 2 (IL-2) in nasal secretions;
Time Frame
The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Title
Detection of inflammatory factor Interleukin 4 (IL-4) in nasal secretions
Description
To test level of inflammatory factor Interleukin 4 (IL-4) in nasal secretions;
Time Frame
The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Title
Detection of inflammatory factor Interleukin 5 (IL-5) in nasal secretions
Description
To test level of inflammatory factor Interleukin 5 (IL-5) in nasal secretions;
Time Frame
The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Title
Detection of inflammatory factor Interleukin 6 (IL-6) in nasal secretions
Description
To test level of inflammatory factor Interleukin 6 (IL-6) in nasal secretions;
Time Frame
The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Title
Detection of inflammatory factor Interleukin 8 (IL-8) in nasal secretions
Description
To test level of inflammatory factor Interleukin 8 (IL-8) in nasal secretions;
Time Frame
The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Title
Detection of inflammatory factor Interleukin 10 (IL-10) in nasal secretions
Description
To test level of inflammatory factor Interleukin 10 (IL-10) in nasal secretions;
Time Frame
The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Title
Detection of inflammatory factor Interleukin 12P70 (IL-12P70) in nasal secretions
Description
To test level of inflammatory factor Interleukin 12P70 (IL-12P70) in nasal secretions;
Time Frame
The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Title
Detection of inflammatory factor Interleukin 17A (IL-17A) in nasal secretions
Description
To test level of inflammatory factor Interleukin 17A (IL-17A) in nasal secretions;
Time Frame
The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Title
Detection of inflammatory factor Tumor necrosis factor-α(TNF-α) in nasal secretions
Description
To test level of inflammatory factor Tumor necrosis factor-α(TNF-α) in nasal secretions;
Time Frame
The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Other Pre-specified Outcome Measures:
Title
Blood routine
Description
Include hemoglobin determination, red blood cell count, white blood cell count white blood cell classification.
Time Frame
The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Title
Urine routine
Description
Include urine color, potential of hydrogen (pH) value of urine, protein qualitative and microscopic determination of urine sediment count.
Time Frame
The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Title
Liver and kidney function
Description
A group of laboratory tests that helps detect problems or disorders in the liver or kidney.
Time Frame
The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Title
Immunological indicators
Description
Cell counts of T cells and their subtypes in peripheral blood
Time Frame
The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Title
Tumor markers
Description
Carcinoembryonic antigen(CEA) ,Alpha-FetoProtein(AFP)
Time Frame
The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
Title
Total Protein Concentration of Nasal Secretions
Description
To determinate the total protein concentration of nasal secretions.
Time Frame
The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with moderate to severe persistent allergic rhinitis who meet the diagnostic criteria for allergic rhinitis (2015 Tianjin standard);
The results of allergen examination showed that the allergen was a single allergy of dust mite;
After more than 2 years of antihistamine, nasal glucocorticoid and other drug treatments, the curative effect is poor, and the symptoms seriously affect the patient's life;
Age 18-60 years old;
The patient refused to receive allergen-specific immunotherapy;
The patient is willing to receive stem cell therapy and sign an informed consent.
Exclusion Criteria:
The subject is accompanied by sinusitis, asthma and aspirin intolerance;
The subjects suffer from severe primary heart, liver, lung, kidney and blood diseases;
The subjects suffer from Malignant tumors;
The subjects suffer from severe immune diseases;
The subjects suffer from mental illness;
Female subjects who are or are about to become pregnant, pregnant or breastfeeding;
Patients who are participating in other clinical trials;
In addition to the above conditions, there are other reasons why researchers believe that they are not suitable to participate in this clinical study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu Zhang, MD
Phone
86 05356691999
Ext
83523
Email
superzhang013@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Peiwen Lian, PhD
Phone
86 05356691999
Ext
82708
Email
lianpeiwen@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xicheng Song, MD
Organizational Affiliation
Yantai Yuhuangding Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yantai Yuhuangding Hospital
City
Yantai
State/Province
Shandong
ZIP/Postal Code
264000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Zhang, MD
Phone
86 05356691999
Ext
83523
Email
superzhang013@163.com
First Name & Middle Initial & Last Name & Degree
Peiwen Lian, PhD
Phone
86 05356691999
Ext
82708
Email
lianpeiwen@qq.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Study of Allergic Rhinitis Therapy by Stem Cells
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