Stem Cell Derived Exome for Treatment of Diabetic Foot

Phase 1

Not yet recruiting

• Conditions: Diabetic Foot; Stem Cell
• Interventions: Drug: Skin drug prepared with exome originated from stem cell

• Registration Number: NCT06480123
• Lead Sponsor: Second Affiliated Hospital of Guangzhou Medical University

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-23
• Study First Submitted QC: 2024-06-26
• Last Update Submitted: 2024-06-26
• Study First Posted: 2024-06-28
• Last Update Posted: 2024-06-28
• Study Start: 2024-08-01
• Primary Completion: 2028-12-30
• Study Completion: 2033-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stem Cell Derived Exome	Skin drug prepared with exome originated from stem cell	-

Primary Outcome Measures

Name	Time	Method
Safety of the treatment	Six months	Safety will be assessed by recording all types of advise effects upon and after the treatment.
Efficacy of the treatment	Six months	Efficacy will be defined as objective response rate + steady disease rate.

Secondary Outcome Measures

Name	Time	Method
Duration of remission (DOR)	5 years	DOR will be defined as the duration of the diabetic foot remission.

Trial Locations

Locations (1)

The Second Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China