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

Chinese Academy of Sciences

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Chronic Nasal Septum Perforation

Treatments: Biological: Collagen membrane + HUC-MSCs

Study type: Interventional

Funder types: Other

Identifiers

NCT02947191

CAS-XDA-NSP/IGDB

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Collagen membrane + HUC-MSCs

Experimental group

Treatment:

Biological: Collagen membrane + HUC-MSCs