Human Cord Blood Mononuclear Cells in the Treatment of Refractory Diabetic Foot
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|ClinicalTrials.gov Identifier: NCT05999656|
Recruitment Status : Recruiting
First Posted : August 21, 2023
Last Update Posted : August 21, 2023
|Condition or disease||Intervention/treatment||Phase|
|Refractory Diabetic Foot Human Cord Blood-derived Mononuclear Cells Efficacy Safety Local Injection||Biological: human cord blood-derived mononuclear cells (HCB-MNCs)||Not Applicable|
Refractory diabetic foot is one of the most serious and costly chronic complications of diabetes, and is the leading cause of nontraumatic lower-extremity amputations. Conventional treatment is symptomatic supportive treatment such as controlling blood sugar, fighting infection, improving blood circulation, using topical medications, etc. But the effectiveness is barely satisfactory, while the wound heals slowly, and the large blood vessels that have been blocked cannot be re-opened. Therefore, an effective method is needed to relieve lower limb ischemia, promote ulcer healing and shorten the treatment time.
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. Cell treatment for diabetic foot include local injection, intravenous infusion and arterial infusion. At present, local intramuscular injection is used in most studies at home and abroad.
HCB-MNCs is composed of immature immune cells and pluripotent stem cells, which is adequate, superior proliferative and immature , is a favorable source of cells for the treatment of diabetic foot. A few clinical studies have found that local intramuscular injection of HCB-MNCs or combined with gel dressing can effectively treat diabetic foot ulcers and relieve pain and other symptoms of patients. In this study, 24 patients with refractory diabetic foot will be enrolled. HCB-MNCs will be injected into the diabetic foot wound area 3 times at a week interval to explore its effectiveness and safety.
The primary objective of this study is to investigate the safety of local application of HCB-MNCs in the treatment of refractory diabetic foot and the change of wound area. The secondary objective is to assess changes in the visual analogue scale, total symptoms score and wagner scale.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Study on the Safety and Efficacy of Local Injection of Human Cord Blood Mononuclear Cells in the Treatment of Refractory Diabetic Foot|
|Actual Study Start Date :||May 28, 2023|
|Estimated Primary Completion Date :||May 28, 2024|
|Estimated Study Completion Date :||November 28, 2024|
Experimental: human cord blood-derived mononuclear cells (HCB-MNCs)
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)
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.
- Number of patients with no adverse reactions. [ Time Frame: 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. ]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.
- Rate of wound area change [ Time Frame: 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. ]
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
- Change in visual analogue scale (VAS) [ Time Frame: 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. ]A Recognized scale containing scores from 0 to 10, with higher scores indicating a worse outcome.
- Change in total symptoms score (TSS) [ Time Frame: 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. ]A Recognized scale containing scores from 0 to 4, with higher scores indicating a worse outcome.
- Change in Wagner scale [ Time Frame: 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. ]A Recognized scale containing levels from 0 to 5, with higher levels indicating a worse outcome.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05999656
|Contact: Xuqin Zhengfirstname.lastname@example.org|
|the First Affiliated Hospital of Nanjing Medical University||Recruiting|
|Contact: Xuqin Zheng 13912902902 email@example.com|
|Study Chair:||Tao Yang||The First Affiliated Hospital with Nanjing Medical University|
|Study Director:||Xuqin Zheng||The First Affiliated Hospital with Nanjing Medical University|