Stem Cell Derived Exome for Treatment of Diabetic Foot

NCT06480123 | Not Yet Recruiting Phase 1

• 1 other identifier: ZZ-SC-EXOME-DF 026
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetic Foot; Stem Cell

Keywords

Diabetic foot; Stem cell; Exome; Skin drug

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Duration of remission (DOR)

  5 years

Study Arms (1)

Stem Cell Derived Exome

EXPERIMENTAL

Drug: Skin drug prepared with exome originated from stem cell

Interventions

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.

Stem Cell Derived Exome

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of diabetic foot.
• Signed informed consent before recruiting.
• Age above 18 years or less than 90 years.
• ECOG score \< 4
• Tolerable coagulation function or reversible coagulation disorders
• 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
• Willing and able to comply with scheduled visits, treatment plan and laboratory tests.

You may not qualify if:

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

Sponsors & Collaborators

• Second Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (1)

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510260, China

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Zhenfeng Zhang, MD, PhD

  Second Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhenfeng Zhang, MD, PhD

CONTACT

+862039195966; zhangzhf@gzhmu.edu.cn

Bingjia He, MD

CONTACT

+862039195965; 464677938@qq.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2024
• First Posted: June 28, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2033
• Last Updated: June 28, 2024

Record last verified: 2024-06

Locations

CN (1)