Stem Cell Derived Exome for Treatment of Diabetic Foot

Skin Drug Prepared From Stem Cell Derived Exome for Treatment of Diabetic Foot: a Phase II Clinical Trial

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

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetic Foot; Stem Cell
• Intervention / Treatment: Drug: Skin drug prepared with exome originated from stem cell

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Bingjia He, MD; Phone Number: +862039195965; Email: 464677938@qq.com
• Study Contact Backup: Name: Zhenfeng Zhang, MD, PhD; Phone Number: +862039195966; Email: zhangzhf@gzhmu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510260
      • The Second Affiliated Hospital of Guangzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stem Cell Derived Exome	Drug: Skin drug prepared with exome originated from stem cell; Skin drug prepared with exome originated from stem cell will be applied to patient with diabetic foot.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of remission (DOR)	DOR will be defined as the duration of the diabetic foot remission.	5 years

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Guangzhou Medical University
• Investigators: Principal Investigator: Zhenfeng Zhang, MD, PhD, Second Affiliated Hospital of Guangzhou Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2033

Study Registration Dates

• First Submitted: June 23, 2024
• First Submitted That Met QC Criteria: June 26, 2024
• First Posted (Actual): June 28, 2024

Study Record Updates

• Last Update Posted (Actual): June 28, 2024
• Last Update Submitted That Met QC Criteria: June 26, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Diabetic foot; Stem cell; Exome; Skin drug
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Ulcer; Diabetic Foot
• Other Study ID Numbers: ZZ-SC-EXOME-DF 026

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No