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Umbilical Cord Mesenchymal Stem Cells Infusion for Diabetes Related Vascular Complications

J

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)

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

Trial contacts and locations

1

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Central trial contact

Jie Shen

Data sourced from clinicaltrials.gov

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