Comparison of Autologous Mesenchymal Stem Cells and Mononuclear Cells on Diabetic Critical Limb Ischemia and Foot Ulcer

NCT00955669 | Completed Phase 1 DMC

• 1 other identifier: ldb2008101
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: To compare the effect and safety of autologous transplantation of bone marrow mesenchymal stem cells(MSCs) and mononuclear cells(MNCs) on Diabetic patients with Critical Limb Ischemia and Foot Ulcer. Methods: patients were randomized into the A group and the B group by use of a randomization table. One lower limb in A group or in B group was selected randomly for MSCs or MNCs transplantation as MSCs or MNCs group, the other lower limb in the same patient was selected for placebo（normal saline ,NS）injection as NS group. The whole procedures of this clinical trial were blinded to both patients and investigators.Patients in both groups received the same ordinary treatment. Meanwhile, MSCs and MNCs were transplanted into the impaired lower limbs respectively. Follow-up index include: efficacy (pain,ulcer healing rate, lower limb amputation rate and ,ankle-brachial index,Transcutaneous oxygen pressure,magnetic resonance angiography) and safety (infection of the injection site, immunological rejection, and tumour generation).

Conditions

Autologous Transplantation; Diabetic Foot

Keywords

mesenchymal stem cells; mononuclear cells

Outcome Measures

Primary Outcomes (1)

• Magnetic resonance angiography

  24 weeks

Study Arms (1)

Symptoms and Objective Examination

ACTIVE COMPARATOR

Biological: Symptoms and Objective Examination

Interventions

Symptoms and Objective Examination BIOLOGICAL

5.0\*108\~5.0\*109 MSCs and MNCs were transplant into impaired lower limbs by intramuscular injection

Also known as: transplant

Symptoms and Objective Examination

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age from 40 to 70 years
• Type 2 diabetic patients
• bilateral critical limb ischemia(ABI from 0.30 to 0.60)
• at least with one foot ulcer

You may not qualify if:

• dry gangrene above the ankle or moist gangrene
• malignant tumor
• severe coronary,cerebral and renal vascular disease

Sponsors & Collaborators

• Third Military Medical University: lead

Study Sites (1)

the southwest Hospital

Chongqing, Chongqing Municipality, 400038, China

Location

Related Publications (2)

• Lu D, Jiang Y, Deng W, Zhang Y, Liang Z, Wu Q, Jiang X, Zhang L, Gao F, Cao Y, Chen B, Xue Y. Long-Term Outcomes of BMMSC Compared with BMMNC for Treatment of Critical Limb Ischemia and Foot Ulcer in Patients with Diabetes. Cell Transplant. 2019 May;28(5):645-652. doi: 10.1177/0963689719835177. Epub 2019 Mar 27.

  PMID: 30917698 DERIVED

• Chen Y, Ma Y, Li N, Wang H, Chen B, Liang Z, Ren R, Lu D, Boey J, Armstrong DG, Deng W. Efficacy and long-term longitudinal follow-up of bone marrow mesenchymal cell transplantation therapy in a diabetic patient with recurrent lower limb bullosis diabeticorum. Stem Cell Res Ther. 2018 Apr 10;9(1):99. doi: 10.1186/s13287-018-0854-9.

  PMID: 29631615 DERIVED

MeSH Terms

Conditions

Diabetic Foot

Interventions

Transplantation

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

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Chen bing, doctor

  Endocrinology and Metabolism Department, the south west Hospital of the Third Military Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 4, 2009
• First Posted: August 10, 2009
• Study Start: August 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: December 1, 2010

Record last verified: 2010-11

Locations

CN (1)