Stem Cell Derived Exome for Treatment of Diabetic Foot

Second Affiliated Hospital of Guangzhou Medical University

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Diabetic Foot; Stem Cell

Treatments: Drug: Skin drug prepared with exome originated from stem cell

Study type: Interventional

Funder types: Other

Identifiers

NCT06480123

ZZ-SC-EXOME-DF 026

Details and patient eligibility

About

This trial is designed to investigate the safety and efficacy of patients with diabetic foot by using stem cell derived exome.

Full description

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Clinical diagnosis of diabetic foot.
2. Signed informed consent before recruiting.
3. Age above 18 years or less than 90 years.
4. ECOG score < 4
5. Tolerable coagulation function or reversible coagulation disorders
6. Laboratory examination test within 7 days prior to procedure: WBC≥3.0×10E9/L; Hb≥90g/L； PLT ≥50×10E9/L；INR < 2.3 or PT < 6 seconds above control；Cr ≤ 145.5 umul/L；Albumin > 28 g/L；Total bilirubin < 51 μmol/L
7. Willing and able to comply with scheduled visits, treatment plan and laboratory tests.

Exclusion criteria

1. Patients participated in clinical trials of equipment or drugs (signed informed consent) within 4 weeks;
2. Patients accompany by ascites, hepatic encephalopathy and esophageal and gastric varices bleeding;
3. Any serious accompanying disease, which is expected to have an unknown, impact on the prognosis, include heart disease, inadequately controlled diabetes and psychiatric disorders;
4. Patients have poor compliance.
5. Allergic to the skin drug;
6. Any agents which could affect the absorption or pharmacokinetics of the study drugs
7. Other conditions that investigator decides not suitable for the trial.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Stem Cell Derived Exome

Experimental group

Treatment:

Drug: Skin drug prepared with exome originated from stem cell