Human Cord Blood Mononuclear Cells in the Treatment of Refractory Diabetic Foot

NCT05999656 | Unknown DMC

• 1 other identifier: 2022-SR-752
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Refractory diabetic foot is one of the most serious and costly chronic complications of diabetes. It is the leading cause of nontraumatic lower-extremity amputations while the conventional treatment is not effective. Therefore, new therapeutic methods are urgently needed. Cell therapy has shown unique advantages and potential in tissue regeneration and wound repair, and is considered as a new effective method to treat diabetic foot. Meanwhile, human cord blood-derived mononuclear cells (HCB-MNCs) with its sufficient sources, strong ability of proliferation and differentiation, and weak immunogenicity, is suitable for the treatment of diabetic foot. It is a prospective, single-arm, single-center clinical study to investigate the efficacy and safety of local injection of HCB-MNCs in the treatment of refractory diabetic foot.

Conditions

Refractory Diabetic Foot; Human Cord Blood-derived Mononuclear Cells; Efficacy; Safety; Local Injection

Outcome Measures

Primary Outcomes (2)

• Number of patients with no adverse reactions.

  The patient completed 3 times HCB-MNCs treatment and follow-up, and there were no adverse reactions that needed to be stopped. Adverse reactions refer to any symptoms, syndromes or diseases that affect patients' health during clinical research and observation, and also include clinically relevant situations found in the laboratory or other diagnostic processes, such as unplanned diagnosis and treatment measures, withdrawal from research, or clinically significant laboratory examination items. Blood routine, fasting blood glucose, postprandial blood glucose, blood biochemistry, coagulation function, tumor markers and adverse reactions will be recorded during the follow-up.

  From baseline to 12 weeks after the first treatment. The follow-up period can be extended up to 24 weeks if the patient's foot ulcers have not healed at 12 weeks.

• Rate of wound area change

  The changes of ulcer wound area were compared weekly before and after local application of HCB-MNCs until the wound heals or the follow-up period ends or the wound area no longer changes. The formula for calculating the change rate of periwound is: Rate of wound area change=(Wound area per week after treatment-Area of wound before treatment)/ Area of wound before treatment×100

  From baseline to 12 weeks after the first treatment. The follow-up period can be extended up to 24 weeks if the patient's foot ulcers have not healed at 12 weeks.

Secondary Outcomes (3)

• Change in visual analogue scale (VAS)

  From baseline to 12 weeks after the first treatment. The follow-up period can be extended up to 24 weeks if the patient's foot ulcers have not healed at 12 weeks.

• Change in total symptoms score (TSS)

  From baseline to 12 weeks after the first treatment. The follow-up period can be extended up to 24 weeks if the patient's foot ulcers have not healed at 12 weeks.

• Change in Wagner scale

  From baseline to 12 weeks after the first treatment. The follow-up period can be extended up to 24 weeks if the patient's foot ulcers have not healed at 12 weeks.

Study Arms (1)

human cord blood-derived mononuclear cells (HCB-MNCs)

EXPERIMENTAL

About 1×10\^8 of HCB-MNCs were injected 3 times at a week interval for each participant.

Biological: human cord blood-derived mononuclear cells (HCB-MNCs)

Interventions

human cord blood-derived mononuclear cells (HCB-MNCs) BIOLOGICAL

All patients received cell therapy for the first time. HCB-MNCs were injected subcutaneously or intramuscularly into the ulcers of the patients' feet, with an interval of about a centimeter between every two points and an injection volume of 0.2ml at each puncture point. The total injection volume required by the patients was the injection needles multiply 0.2ml (about 2ml of suspended cell in total). The remaining suspension was injected on both sides of the center of the main ischemic site. All patients received three injections of umbilical cord blood mononuclear cells at a week interval, with the latter two injections located around the site of the first injection. The adjuvant therapy remained unchanged within two weeks after cell injection. The follow-up period is 12 weeks after treatment to observe safety and efficacy. If the patient does not recover after 12 weeks, the follow-up period can be extended to 24 weeks.

human cord blood-derived mononuclear cells (HCB-MNCs)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-80 years;
• Meet the diagnostic criteria of diabetic foot by International Clinical Guidelines for Diabetic Foot;
• Ulcer course ≥8 weeks, Wagner grade ≥2;
• There was no healing trend (no reduction in wound size and no obvious new granulation tissue) after 4 weeks or above treatment. Or the ulcer was further aggravated (by Wagner's grade assessment) in the course of standardized treatment;
• Fasting blood glucose ≤9mmol/L, 2h postprandial blood glucose ≤13mmol/L;
• Signing informed consent.

You may not qualify if:

• Patients with a history of ketoacidosis and hyperosmosis within 6 months;
• Patients with viral infection (treponema pallidum, active hepatitis, HIV, Epstein-Barr virus, etc.)
• Patients with malignant disease or cured of basal cell carcinoma within the past 5 years;
• Creatinine clearance \< 45ml/min;
• Patients with severe heart failure (NYHA III-IV);
• Patients with a history of myocardial infarction or cerebral infarction in the last 3 months;
• Patients who have received cell or growth factor therapy in the past year;
• Patients during pregnancy or lactation;
• Patients with abnormal thyroid dysfunction history or abnormal control through drug treatment;
• Patients with severe hepatic failure (ALT, AST: above 3 times the upper limit of normal);
• Lower extremity arterial with large artery occlusion by ultrasound image;
• Patients with a history of severe coagulation disorder or hemorrhagic disease;
• Patients with sequelae of cerebral infarction or other reasons that cannot extend their lower limbs flat;
• Patients with psychological or mental disorders who cannot cooperate with treatment;
• Participate in other clinical research within the past three months;

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• Shandong Qilu Stem Cells Engineering Co., Ltd.: collaborator

Study Sites (1)

the First Affiliated Hospital of Nanjing Medical University

Nanjing, China

RECRUITING

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

• Tao Yang

  The First Affiliated Hospital with Nanjing Medical University

  STUDY CHAIR

• Xuqin Zheng

  The First Affiliated Hospital with Nanjing Medical University

  STUDY DIRECTOR

Central Study Contacts

Xuqin Zheng

CONTACT

13912902902; zhengxuqin@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2023
• First Posted: August 21, 2023
• Study Start: May 28, 2023
• Primary Completion: May 28, 2024
• Study Completion: November 28, 2024
• Last Updated: August 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)