Umbilical Cord Mesenchymal Stem Cells Infusion for Diabetes Related Vascular Complications

Jie Shen

Status and phase: Unknown; Phase 1

Conditions: Diabetic Foot; Peripheral Vascular Disease; Ischemia

Treatments: Biological: Umbilical Cord Mesenchymal Stem Cells; Biological: saline

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02834858

ThirdSouthernMedical1

Details and patient eligibility

About

Stem cell therapy has been a new and effective therapy in recent years for diabetic foot.This study intends to establish an optimal clinical research program, and attempts to break the technical bottleneck in the stem cell therapy for treating diabetes related vascular complications.

Full description

Diabetic foot is one of the most serious chronic complications of diabetic patients, and still lacking effective treatments.

Stem cell therapy has been a new and effective therapy in recent years for diabetic foot. Combined with the previous studies of the investigators research group, this study intends to transform part of the results of this research, establish an optimal clinical research program, and attempts to break the technical bottleneck in the stem cell therapy for treating diabetes related vascular complications.

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diabetes mellitus Type 2 or Type 1
• Age between 18-80 years
• Chronic foot ulcer more than 6 weeks
• No sufficient response to best standard care delivered for six weeks.
• PAD up to Fontaine stage III or IV period
• CLI with the ankle brachial index (index ankle-brachial, ABI) <0.7 and (or) the percutaneous oxygen partial pressure (oxygen tension transcutaneous, TcPO2) <30mmHg

Exclusion criteria

• HbA1c >12%
• Hemoglobin <10 mg/dl
• Creatinine clearance rate <30ml/min
• Systemic bacterial, viral infections (Mei Du, hepatitis, cytomegalovirus infection, - HIV, B19 infection, herpes virus infection) and sepsis
• Have accepted the treatment of stem cells or growth factors
• Have a history of malignant disease
• Pregnancy
• Mental illness history
• Abnormal coagulation function
• Allergic reaction
• Severe cardiac insufficiency (III-IV NYHA)
• Using vasoactive substances

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups, including a placebo group

Umbilical Cord Mesenchymal Stem Cells

Experimental group

Description:

Umbilical Cord Mesenchymal Stem Cells Infusion.

Treatment:

Biological: Umbilical Cord Mesenchymal Stem Cells

saline

Placebo Comparator group

Description:

saline injection

Treatment:

Biological: saline