Collagen Membrane Combined With HUC-MSCs Transplantation in Patients With Nasal Septum Perforation
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ClinicalTrials.gov Identifier: NCT02947191 |
Recruitment Status : Unknown
Verified October 2016 by Jianwu Dai, Chinese Academy of Sciences.
Recruitment status was: Active, not recruiting
First Posted : October 27, 2016
Last Update Posted : January 5, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Nasal Septum Perforation | Biological: Collagen membrane + HUC-MSCs | Phase 1 Phase 2 |
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 2021 |
Estimated Study Completion Date : | December 2021 |

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. |
- The change of integrity of nasal septum assessed by endoscopic examination [ Time Frame: baseline, 1,2,3,4,8,12 weeks after surgery ]
- The change of nasal mucosal physiology assessed by olfactory test [ Time Frame: baseline, 12 weeks after surgery ]
- The change of nasal mucosal physiology assessed by nasal mucociliary clearance time (MCT) [ Time Frame: baseline, 12 weeks after surgery ]
- The change of nasal airway resistance assessed by rhinomanometry [ Time Frame: baseline, 12 weeks after surgery ]
- The change of nasal obstruction assessed by acoustic rhinometry [ Time Frame: baseline, 12 weeks after surgery ]
- The change of nasal obstructive symptom assessed by visual analogue scale (VAS) [ Time Frame: baseline, 12 weeks after surgery ]
- The change of nasal symptom severity assessed by total nasal symptom score (TNSS) [ Time Frame: baseline, 12 weeks after surgery ]
- Change from baseline in computed tomography (CT) [ Time Frame: baseline, 12 weeks after surgery ]

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with nasal septum perforation area less than 1cm², and requires minimally-invasive treatment.
- Male or female, 18-45 years old.
- Ability and willingness to regular visit to hospital and follow up during the protocol Procedures.
Exclusion Criteria:
- Cystic fibrosis, immotile cilia syndrome and other genetic diseases.
- Syphilis, leprosy, tuberculosis and other specific infections.
- Severe Sinusitis.
- Autoimmune diseases or long term treatment with corticosteroids.
- Alzheimer's disease.
- Systemic diseases (e.g.,hypertension, diabetes and so on).
- Previous history of nasal cancer or after receiving radiotherapy.
- Drug abuse.
- History of mental illness.

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
China, Jiangsu | |
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | |
Nanjing, Jiangsu, China, 210008 |
Principal Investigator: | Jianwu Dai, Ph.D | Chinese Academy of Sciences |
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 |
Other Study ID Numbers: |
CAS-XDA-NSP/IGDB |
First Posted: | October 27, 2016 Key Record Dates |
Last Update Posted: | January 5, 2021 |
Last Verified: | October 2016 |
Nasal Septal Perforation Nose Diseases Respiratory Tract Diseases Otorhinolaryngologic Diseases Wounds and Injuries |