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Collagen Membrane Combined With HUC-MSCs Transplantation in Patients With Nasal Septum Perforation

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ClinicalTrials.gov Identifier: NCT02947191
Recruitment Status : Recruiting
First Posted : October 27, 2016
Last Update Posted : November 22, 2016
Sponsor:
Collaborator:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Information provided by (Responsible Party):
Jianwu Dai, Chinese Academy of Sciences

Study Description
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Brief Summary:
The purpose of this study is to assess the safety and efficacy of collagen membrane combined with human clinical grade umbilical cord mesenchymal stem cells(HUC-MSCs) transplantation in patients with chronic nasal septum perforation.

Condition or disease Intervention/treatment Phase
Chronic Nasal Septum Perforation Biological: Collagen membrane + HUC-MSCs Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Safety and Efficacy Assessment of Collagen Membrane Combined With Human Umbilical Cord Mesenchymal Stem Cells (HUC-MSCs) Transplantation in Patients With Nasal Septum Perforation
Study Start Date : November 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Collagen membrane + HUC-MSCs Biological: Collagen membrane + HUC-MSCs
After separating bilateral nasal septum mucosas via septum reconstruction incision under endoscopy, the clinical grade HUC-MSCs combined with collagen membrane will be transplanted between the bilateral nasal septum mucosas and fixed. The patients will be treated with antibiotics for 1 week, and with naristillae menthae compositae, mucus promoting agent and other drugs for improving microcirculation for 1 month.


Outcome Measures
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Primary Outcome Measures :
  1. The change of integrity of nasal septum assessed by endoscopic examination [ Time Frame: baseline, 1,2,3,4,8,12 weeks after surgery ]

Secondary Outcome Measures :
  1. The change of nasal mucosal physiology assessed by olfactory test [ Time Frame: baseline, 12 weeks after surgery ]
  2. The change of nasal mucosal physiology assessed by nasal mucociliary clearance time (MCT) [ Time Frame: baseline, 12 weeks after surgery ]
  3. The change of nasal airway resistance assessed by rhinomanometry [ Time Frame: baseline, 12 weeks after surgery ]
  4. The change of nasal obstruction assessed by acoustic rhinometry [ Time Frame: baseline, 12 weeks after surgery ]
  5. The change of nasal obstructive symptom assessed by visual analogue scale (VAS) [ Time Frame: baseline, 12 weeks after surgery ]
  6. The change of nasal symptom severity assessed by total nasal symptom score (TNSS) [ Time Frame: baseline, 12 weeks after surgery ]
  7. Change from baseline in computed tomography (CT) [ Time Frame: baseline, 12 weeks after surgery ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with nasal septum perforation area less than 1cm², and requires minimally-invasive treatment.
  2. Male or female, 18-45 years old.
  3. Ability and willingness to regular visit to hospital and follow up during the protocol Procedures.

Exclusion Criteria:

  1. Cystic fibrosis, immotile cilia syndrome and other genetic diseases.
  2. Syphilis, leprosy, tuberculosis and other specific infections.
  3. Severe Sinusitis.
  4. Autoimmune diseases or long term treatment with corticosteroids.
  5. Alzheimer's disease.
  6. Systemic diseases (e.g.,hypertension, diabetes and so on).
  7. Previous history of nasal cancer or after receiving radiotherapy.
  8. Drug abuse.
  9. History of mental illness.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02947191


Contacts
Contact: Chenjie Yu, M.D. entphd@163.com
Contact: Sufang Han, Ph.D 86-10-82614420 sufanghan22@genetics.ac.cn

Locations
China, Jiangsu
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Recruiting
Nanjing, Jiangsu, China, 210008
Contact: Chenjie Yu    86-25-83304616 ext 61131    entphd@163.com   
Sponsors and Collaborators
Chinese Academy of Sciences
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Investigators
Principal Investigator: Jianwu Dai, Ph.D Chinese Academy of Sciences
More Information
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Responsible Party: Jianwu Dai, Principal Investigator of Regenerative Medicine Laboratory, Institute of Genetics and Developmental Biology, CAS, Chinese Academy of Sciences
ClinicalTrials.gov Identifier: NCT02947191     History of Changes
Other Study ID Numbers: CAS-XDA-NSP/IGDB
First Posted: October 27, 2016    Key Record Dates
Last Update Posted: November 22, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Nasal Septal Perforation
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Wounds and Injuries