Clinical Study of Adipose-derived Stem Cells in the Treatment of Diabetic Foot

NCT03916211 | Unknown Early Phase 1 DMC

• 1 other identifier: SC-2018-04-02
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.Program Name: Clinical Study on Treatment of Diabetic Foot with Autologous Adipose Stem Cells
2. 2.Bidding Unit: Tenth People's Hospital Affiliated to Tongji University
3. 3.Study subjects: diabetic foot patients
4. 4.OBJECTIVE: To establish an autologous adipose stem cell therapy for diabetic foot and evaluate its clinical safety and efficacy.
5. 5.Study Design: Randomized Controlled Clinical Study
6. 6.Target number of cases: 60
7. 7.Main evaluation indicators: ulcer healing and amputation, calculating ulcer healing rate = total wound healing cases / total ulcer cases in this group; amputation rate = amputation cases / total cases in this group.
8. 8.Secondary evaluation indicators: ankle-brachial index (ABI), Ruthford classification, painless walking time Wong-Baker Faces pain score, transcutaneous partial pressure of oxygen (TcPO2), laser Doppler flowmetry, multi-slice spiral CT angiography (CTA)

Conditions

Diabetes Mellitus Foot Ulcer

Keywords

stem cells

Outcome Measures

Primary Outcomes (2)

• ulcer healing rate

  Ulcer healing rate = number of cases of complete wound healing / total number of ulcers in this group

  up to 4 weeks

• amputation rate

  Amputation rate = number of amputations / total number of amputations in this group

  up to 4 weeks

Secondary Outcomes (6)

• ultrasound

  2 weeks

• ABI(ankle brachial index)

  2weeks

• TcPO2（Transcutaneous oxygen pressure）

  2 weeks

• CTA(Computed Tomography angiography)

  up to 4 weeks

• Rutherford Classification

  2 weeks

Study Arms (2)

routine treatment

NO INTERVENTION

Diabetic foot routine treatment without intervention

MSCs treatment

EXPERIMENTAL

On the basis of routine treatment of diabetic foot, adipose stem cells will be added to treat diabetic foot

Biological: MSCs treatment

Interventions

MSCs treatment BIOLOGICAL

intramuscular injection of adipose stem cells treat diabetic foot

MSCs treatment

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The age ranges from 30 to 65 years. There is no limit for male and female inpatients and outpatients who can be followed up.
• It conforms to the diagnostic criteria of diabetic foot of the sixth edition of Medical College Textbook Internal Medicine of the Ministry of Health.
• Severe lower limb ischemia (defined as resting ankle-brachial index (ABI) 0.4-0.8, accompanied by resting pain or intermittent claudication);
• The expected survival time is longer than one year.
• No human specific viruses (including HIV, HBV, HCV, HTLV, EBV, CMV, etc.) were detected and screened, and no Treponema pallidum infection was found.
• Voluntary subjects, the subjects understand the content of the experiment, and voluntarily sign the informed consent before the beginning of the experiment.

You may not qualify if:

• Diabetic retinopathy;
• There are allergies or contraindications to antiplatelet drugs, anticoagulants, thrombolytics, contrast agents, salicylates, etc.
• Haemorrhagic tendency, coagulation dysfunction, hypercoagulable constitution or refusal of transfusion therapy exist.
• In the past five years, patients with malignant diseases or markedly elevated levels of tumor markers in the blood were definitely diagnosed (the estimated survival time was less than 12 months).
• Pre-acute infectious disease symptoms;
• Patients with severe liver diseases (such as ascites, esophageal varices, liver transplantation, etc.); hemodynamic instability; renal failure undergoing dialysis; immunosuppressive therapy; decompensated heart failure (New York Heart Association Class III or IV) or myocardial infarction or bypass heart transplantation within three months before the start of the study; Hemorrhagic or ischemic stroke within 3 months before onset;
• Patients who are still participating in other clinical trials;
• Other researchers consider that patients who are not eligible for enrollment have other concomitant diseases.
• Subjects who refused to sign the informed consent or participate in the clinical trial.
• Immunodeficiency patients;

Sponsors & Collaborators

• Maoquan Li: lead

Related Publications (15)

• Lu Debin, Jiang Youzhao, Liang Ziwen, Li Xiaoyan, Zhang Zhonghui, Chen Bing.Autologous transplantation of bone marrow mesenchymal stem cells on diabetic patients with lower limb ischemia.Journal of Medical Colleges of PLA 2008;23:106-115

  BACKGROUND

• Carlin JB, Doyle LW. Sample size. J Paediatr Child Health. 2002 Jun;38(3):300-4. doi: 10.1046/j.1440-1754.2002.00855.x. No abstract available.

  PMID: 12047701 BACKGROUND

• Al-Delaimy WK, Merchant AT, Rimm EB, Willett WC, Stampfer MJ, Hu FB. Effect of type 2 diabetes and its duration on the risk of peripheral arterial disease among men. Am J Med. 2004 Feb 15;116(4):236-40. doi: 10.1016/j.amjmed.2003.09.038.

  PMID: 14969651 BACKGROUND

• Khattab AD, Ali IS, Rawlings B. Peripheral arterial disease in diabetic patients selected from a primary care setting: Implications for nursing practice. J Vasc Nurs. 2005 Dec;23(4):139-48. doi: 10.1016/j.jvn.2005.09.005.

  PMID: 16326332 BACKGROUND

• Rathur HM, Boulton AJ. The diabetic foot. Clin Dermatol. 2007 Jan-Feb;25(1):109-20. doi: 10.1016/j.clindermatol.2006.09.015.

  PMID: 17276208 BACKGROUND

• Dick F, Diehm N, Galimanis A, Husmann M, Schmidli J, Baumgartner I. Surgical or endovascular revascularization in patients with critical limb ischemia: influence of diabetes mellitus on clinical outcome. J Vasc Surg. 2007 Apr;45(4):751-61. doi: 10.1016/j.jvs.2006.12.022. Epub 2007 Feb 15.

  PMID: 17306950 BACKGROUND

• Engelhardt M, Bruijnen H, Scharmer C, Jezdinsky N, Wolfle K. Improvement of quality of life six months after infrageniculate bypass surgery: diabetic patients benefit less than non-diabetic patients. Eur J Vasc Endovasc Surg. 2006 Aug;32(2):182-7. doi: 10.1016/j.ejvs.2006.02.007. Epub 2006 Mar 29.

  PMID: 16567116 BACKGROUND

• Huang P, Li S, Han M, Xiao Z, Yang R, Han ZC. Autologous transplantation of granulocyte colony-stimulating factor-mobilized peripheral blood mononuclear cells improves critical limb ischemia in diabetes. Diabetes Care. 2005 Sep;28(9):2155-60. doi: 10.2337/diacare.28.9.2155.

  PMID: 16123483 BACKGROUND

• Humpert PM, Bartsch U, Konrade I, Hammes HP, Morcos M, Kasper M, Bierhaus A, Nawroth PP. Locally applied mononuclear bone marrow cells restore angiogenesis and promote wound healing in a type 2 diabetic patient. Exp Clin Endocrinol Diabetes. 2005 Oct;113(9):538-40. doi: 10.1055/s-2005-872886.

  PMID: 16235157 BACKGROUND

• Canizo MC, Lozano F, Gonzalez-Porras JR, Barros M, Lopez-Holgado N, Briz E, Sanchez-Guijo FM. Peripheral endothelial progenitor cells (CD133 +) for therapeutic vasculogenesis in a patient with critical limb ischemia. One year follow-up. Cytotherapy. 2007;9(1):99-102. doi: 10.1080/14653240601034708.

  PMID: 17354105 BACKGROUND

• Kern S, Eichler H, Stoeve J, Kluter H, Bieback K. Comparative analysis of mesenchymal stem cells from bone marrow, umbilical cord blood, or adipose tissue. Stem Cells. 2006 May;24(5):1294-301. doi: 10.1634/stemcells.2005-0342. Epub 2006 Jan 12.

  PMID: 16410387 BACKGROUND

• De Ugarte DA, Morizono K, Elbarbary A, Alfonso Z, Zuk PA, Zhu M, Dragoo JL, Ashjian P, Thomas B, Benhaim P, Chen I, Fraser J, Hedrick MH. Comparison of multi-lineage cells from human adipose tissue and bone marrow. Cells Tissues Organs. 2003;174(3):101-9. doi: 10.1159/000071150.

  PMID: 12835573 BACKGROUND

• Zuk PA, Zhu M, Ashjian P, De Ugarte DA, Huang JI, Mizuno H, Alfonso ZC, Fraser JK, Benhaim P, Hedrick MH. Human adipose tissue is a source of multipotent stem cells. Mol Biol Cell. 2002 Dec;13(12):4279-95. doi: 10.1091/mbc.e02-02-0105.

  PMID: 12475952 BACKGROUND

• Gimble JM, Katz AJ, Bunnell BA. Adipose-derived stem cells for regenerative medicine. Circ Res. 2007 May 11;100(9):1249-60. doi: 10.1161/01.RES.0000265074.83288.09.

  PMID: 17495232 BACKGROUND

• Wei Y, Hu H, Wang H, Wu Y, Deng L, Qi J. Cartilage regeneration of adipose-derived stem cells in a hybrid scaffold from fibrin-modified PLGA. Cell Transplant. 2009;18(2):159-70. doi: 10.3727/096368909788341261.

  PMID: 19499704 BACKGROUND

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

• Li Xue, ph.D

  Shanghai 10th People'sHospital

  STUDY DIRECTOR

Central Study Contacts

Li Maoquan, ph.D

CONTACT

02166313506; cjr.limaoquan@vip.163.com

Xie Xiaoyun, ph.D

CONTACT

02166313506; xiaoyunxietj@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. Li

Study Record Dates

• First Submitted: April 10, 2019
• First Posted: April 16, 2019
• Study Start: April 20, 2019
• Primary Completion: January 31, 2020
• Study Completion: March 31, 2020
• Last Updated: April 16, 2019

Record last verified: 2019-04