A Clinical Study Using Autologous Bone Marrow Stem Cell for Diabetes Related Vascular Complications
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Peripheral Vascular Disease
- Sponsor
- Jie Shen
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- Area of diabetic foot ulcers
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Detailed 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 our 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.
Investigators
Jie Shen
doctor
The Third Affiliated Hospital of Southern Medical University
Eligibility Criteria
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
Outcomes
Primary Outcomes
Area of diabetic foot ulcers
Time Frame: 3 months
To determine the ability of MSC to facilitate and accelerate diabetic foot ulcers healing.
Secondary Outcomes
- Improvement of transcutaneous oxygen partial pressure (TcPO2)(3 months)
- Improvement of microvascular cutaneous reactivity by laser Doppler perfusion monitoring (LDPM)(3 months)
- Pain (Visual-Analog Scale)(3 months)
- Walking distance (treadmill) if possible(3 months)