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This trial is designed to investigate the safety and efficacy of patients with diabetic foot by using stem cell derived exome.
It is estimated that about 150 million people are suffering diabetes mellitus, of whom more than 15% will develop foot ulcers or gangrene at some times, so called diabetic foot. The diabetic foot is very difficult to cure by traditional approaches.
This phase I clinical trial is designed to assess the safety and theraputical benefit of the stem cell derived exome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stem Cell Derived Exome | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Skin drug prepared with exome originated from stem cell | Drug | Skin drug prepared with exome originated from stem cell will be applied to patient with diabetic foot. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of the treatment | Safety will be assessed by recording all types of advise effects upon and after the treatment. | Six months |
| Efficacy of the treatment | Efficacy will be defined as objective response rate + steady disease rate. | Six months |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of remission (DOR) | DOR will be defined as the duration of the diabetic foot remission. | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhenfeng Zhang, MD, PhD | Contact | +862039195966 | zhangzhf@gzhmu.edu.cn | |
| Bingjia He, MD | Contact | +862039195965 | 464677938@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhenfeng Zhang, MD, PhD | Second Affiliated Hospital of Guangzhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | 510260 | China |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |