Stem Cell Therapy for Patients With Vascular Occlusive Diseases Such as Diabetic Foot

NCT02304588 | Unknown Phase 1 DMC

• 1 other identifier: CHIN-PLAGH-ST-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Mesenchymal stem cells with multidirectional differentiation potential,autologous stem cell transplantation into ischemic foot, make its differentiation to form new blood capillary, improve and restore the local blood flow.

Conditions

Diabetic Foot; Lower Limb Ischemia

Outcome Measures

Primary Outcomes (1)

• Frequency of Adverse Events

  Frequency and severity of Adverse Events

  6 months

Secondary Outcomes (1)

• Relative Wound Area Regression of 40% or More at 6 Week

  6 week

Other Outcomes (1)

• Reduced pain

  6 months after treatment

Study Arms (1)

Mesenchymal stem cells

EXPERIMENTAL

Maximal amount of MSC cells injected: 10-20\*10\^6 cells (up to volume of 20mL, depending on the wound size \& patient weight).

Biological: Mesenchymal stem cells

Interventions

Mesenchymal stem cells BIOLOGICAL

10-20 x 10\^6 cells/20mL

Mesenchymal stem cells

Eligibility Criteria

• Age: 30 Years - 78 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• the age of 30-78 years old, men and women there is no limit.
• in accordance with the ministry of health in higher medical colleges and universities teaching material the sixth edition of the annals of diabetic foot diagnostic criteria.
• with severe lower limb ischemia (defined as the resting state of ankle brachial index (ABI) 0.4-0.85, accompanied by resting or intermittent toe line.
• treatment on a voluntary basis, and sign the informed consent.

You may not qualify if:

• with severe heart, liver, kidney, lung function failure or general condition is very poor can't tolerate the stem cell transplant.
• clear over the past five years tumor markers in patients with malignant disease and blood levels increased significantly.
• the prodrome of acute infectious diseases.
• participated in clinical subjects within three months before test.
• adherence is poor, can not complete the course.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100039, 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

• xiaobing FU

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

xiaobing FU

CONTACT

+86(10)937516

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Academician

Study Record Dates

• First Submitted: November 12, 2014
• First Posted: December 2, 2014
• Study Start: January 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2017
• Last Updated: December 2, 2014

Record last verified: 2014-11

Locations

CN (1)