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Umbilical Cord Mesenchymal Stem Cells Injection for Diabetes Secondary Peripheral Arterial Disease

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ClinicalTrials.gov Identifier: NCT02287831
Recruitment Status : Unknown
Verified February 2016 by Pingping Huang, Institute of Hematology & Blood Diseases Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : November 11, 2014
Last Update Posted : February 25, 2016
Sponsor:
Information provided by (Responsible Party):
Pingping Huang, Institute of Hematology & Blood Diseases Hospital

Brief Summary:
The purpose of this study is to assess the safety and efficacy of umbilical cord mesenchymal stem cells in diabetes with peripheral arterial disease.

Condition or disease Intervention/treatment Phase
Diabetes Peripheral Arterial Disease Biological: umbilical cord mesenchymal stem cells Phase 1 Phase 2

Detailed Description:
Diabetes is a common chronic disease with significant morbidity and mortality. One devastating complication of diabetes is peripheral arterial disease (PAD), which may result in limb loss.In our study,patients were divided into 3 dose treatment groups (6.29 × 107,9.43 × 107 and 14.15 × 107 cells/m2)。After 4 and 8 weeks, patients were injected the same number of cells. Follow-up index include: efficacy (pain,cold, numbness, Intermittent claudication distance, skin temperature,limb cyanosis area, area and depth of ulcers, gangrene range,ankle-brachial index, Transcutaneous partial pressure of oxygen ,lower limb amputation rate and , blood perfusion, Digital subtraction angiography) and safety (infection of the injection site, and tumour generation).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell Injection for Diabetes Secondary Peripheral Arterial Disease
Study Start Date : February 2014
Estimated Primary Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: umbilical cord mesenchymal stem cells
Multiple intra muscular injection of mesenchymal stem cells derived from human umbilical cord.
Biological: umbilical cord mesenchymal stem cells
patients were divided into 3 dose treatment groups (6.29 × 107,9.43 × 107 and 14.15 × 107 cells/m2). After 4 and 8 weeks, patients were injected the same number of cells.




Primary Outcome Measures :
  1. Angiographic evaluation of angiogenesis at ischemic limb [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Ankle-Brachial pressure index [ Time Frame: 3 months ]
    Self-control,compared with non-treatment ABI≧0.01

  2. Walking distance [ Time Frame: 3 months ]
  3. Pain [ Time Frame: 3 months ]
    Rest pains on rating scales ranged from 0 points for the best (complete relief of pain with no use of analgesics) to 4 points for the worst result.Self-control,compared with non-treatment ,the score≧1.

  4. Laser Doppler evaluation of blood perfusion at ischemic limb [ Time Frame: 3 months ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age of 18-75 years
  2. Patients confirmed diagnosed with diabetes secondary to peripheral vascular disease , ankle-brachial index < 0.9
  3. Poor distal arterial outflow tract
  4. Patient had at least 3 months conservative treatment ,which resulted in little or no improvement
  5. Poor physical condition can not tolerate surgery
  6. Patients are willing to participate in the study and sign the informed consent.

Exclusion Criteria:

  1. Renal function damage (over 2 X upper normal range) Liver function damage (over 3 X upper normal range )
  2. Severe or acute organ damage
  3. Presence of malignancy
  4. Pregnancy or lactating patients
  5. HIV positive
  6. ABI≧0.9
  7. A history of severe allergies related cell therapy
  8. Conservative treatment < 3 months
  9. Acute limb ischemia
  10. Local obvious infection uncontrolled
  11. Alcoholics or drug abusers within a year
  12. Severe psychiatric disorder.
  13. Patients need surgical treatment
  14. Above the ankle gangrene
  15. Patients with other factors which were considered not to be suitable to participate in the study by the investigators.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02287831


Sponsors and Collaborators
Institute of Hematology & Blood Diseases Hospital
Investigators
Principal Investigator: Pingping Huang, M.D. Institute of Hematology & Blood Diseases Hospital

Responsible Party: Pingping Huang, M.D., Institute of Hematology & Blood Diseases Hospital
ClinicalTrials.gov Identifier: NCT02287831     History of Changes
Other Study ID Numbers: 13ZCZDSY02200
First Posted: November 11, 2014    Key Record Dates
Last Update Posted: February 25, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Peripheral Arterial Disease
Peripheral Vascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases