NCT05151133

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2022

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2021

Completed
29 days until next milestone

First Posted

Study publicly available on registry

December 9, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

June 13, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2024

Completed
Last Updated

March 28, 2023

Status Verified

March 1, 2023

Enrollment Period

2.5 years

First QC Date

November 10, 2021

Last Update Submit

March 26, 2023

Conditions

Allergic Rhinitis

Keywords

Umbilical cordMesenchymal Stem CellsAllergic RhinitisTherapy

Outcome Measures

Primary Outcomes (8)

  • 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.

    Day 1 of treatment

  • 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.

    3 days after treatment

  • 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 week after treatment

  • 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.

    1 month after treatment

  • 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.

    3 months after treatment

  • 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.

    6 months after treatment

  • 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.

    12 months after treatment

  • 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.

    24 months after treatment

Secondary Outcomes (29)

  • RQLQ score

    The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.

  • VAS score

    The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.

  • Nasal function test

    The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.

  • Nasal endoscopy

    The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.

  • U-HCG

    The day of enrollment screening, 3 months, 6 months, 12 months, and 24 months after the treatment.

  • +24 more secondary outcomes

Other Outcomes (6)

  • Blood routine

    The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.

  • Urine routine

    The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.

  • Liver and kidney function

    The day of enrollment screening, the 3rd day, 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months after the treatment.

  • +3 more other outcomes

Study Arms (3)

Low dose UCMSCs

EXPERIMENTAL
Biological: Low dose UCMSCs

Moderate dose UCMSCs

EXPERIMENTAL
Biological: Moderate dose UCMSCs

High dose UCMSCs

EXPERIMENTAL
Biological: High dose UCMSCs

Interventions

Low dose UCMSCsBIOLOGICAL

Receive one course of treatment with a single injection : 0.5×10\^6 cells/kg, with a total volume of 100 ml UCMSCs;

Low dose UCMSCs
Moderate dose UCMSCsBIOLOGICAL

Receive one course of treatment with a single injection : 1.0×10\^6 cells/kg, with a total volume of 100 ml UCMSCs;

Moderate dose UCMSCs
High dose UCMSCsBIOLOGICAL

Receive one course of treatment with a single injection : 2.0×10\^6 cells/kg, with a total volume of 100 ml UCMSCs;

High dose UCMSCs

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yantai Yuhuangding Hospital

Yantai, Shandong, 264000, China

RECRUITING

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Xicheng Song, MD

    Yantai Yuhuangding Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu Zhang, MD

CONTACT

86 05356691999superzhang013@163.com

Peiwen Lian, PhD

CONTACT

86 05356691999lianpeiwen@qq.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2021

First Posted

December 9, 2021

Study Start

June 13, 2022

Primary Completion

December 15, 2024

Study Completion

December 15, 2024

Last Updated

March 28, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)