COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02947191
Recruitment Status : Recruiting
First Posted : October 27, 2016
Last Update Posted : January 13, 2020
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Information provided by (Responsible Party):
Jianwu Dai, Chinese Academy of Sciences

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
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 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen

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.

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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT02947191

Layout table for location contacts
Contact: Chenjie Yu, M.D.
Contact: Sufang Han, Ph.D 86-10-82614420

Layout table for location information
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   
Sponsors and Collaborators
Chinese Academy of Sciences
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Layout table for investigator information
Principal Investigator: Jianwu Dai, Ph.D Chinese Academy of Sciences

Layout table for additonal information
Responsible Party: Jianwu Dai, Principal Investigator of Regenerative Medicine Laboratory, Institute of Genetics and Developmental Biology, CAS, Chinese Academy of Sciences Identifier: NCT02947191    
Other Study ID Numbers: CAS-XDA-NSP/IGDB
First Posted: October 27, 2016    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: October 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Nasal Septal Perforation
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Wounds and Injuries