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Autologous Bone Marrow Mononuclear Cells Therapy in Diabetic Lower Limb Ischemia

3. december 2013 opdateret af: Quanhai Li, Hebei Medical University

Safety and Efficacy Investigation of Patients With Diabetic Lower Limb Ischemia by Transplantation of Autologous Bone Marrow Mononuclear Cells

This study is to evaluate the safety and efficacy of autologous bone marrow mononuclear cells transplantation in diabetic patients with lower limb ischemia.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Diabetic lower limb ischemia as severe complication of diabetes influences the life quality of patients and currently the effective treatment for the disease is lacking. Bone marrow mononuclear cells have been proved to have multiple functions including the differentiation and proliferation. In animal model, bone marrow mononuclear cells could induce angiogenesis and may have therapeutic usage for ischemia disease. The investigators thereby design the study to investigate the possible therapy of diabetic lower limb ischemia with autologous bone marrow mononuclear cells. Patient with diabetic lower limb ischemia was treated with colony stimulating factor for improvement of bone marrow hematopoiesis. Then bone marrow was taken and mononuclear cells were isolated with deleting erythrocyte by density gradient centrifugation. Bone marrow mononuclear cells were transplanted into ischemia regions of lower limb through intramuscular injection. The investigators investigated the safety of the therapy with life signs like temperature, pulse, blood pressure, routine analysis of blood and urine etc. post the transplantation. And the efficacy was evaluated with the measurement of ulcer size, rest pain score, cold sensation score, resting ABI, resting TcPO2, collateral vessel score and skin microcirculation.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

10

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
    • Hebei
      • Shijiazhuang, Hebei, Kina, 050000
        • Rekruttering
        • The First Hospital of Hebei Medical University
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. fontaine's stage 2-4 or resting ABI <0.7
  2. age between 20 and 80 years old
  3. sign informed consent, voluntary subjects
  4. diagnosis of diabetic lower limb ischemia

Exclusion Criteria:

  1. poorly controlled diabetes (HBA1c> 7.0%) and proliferative retinopathy (III-IV stage)
  2. malignancy history in the past five years or serum level of tumor markers elevated more than doubled
  3. severe heart, liver, kidney, respiratory failure or poor general condition can not tolerate bone marrow mononuclear cells transplantation
  4. serious infections (such as cellulitis, osteomyelitis, etc.)
  5. pregnant female, or reproductive age female who wants to give birth throughout the course of the study
  6. life expectancy less than half a year

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: autologous bone marrow mononuclear cells
Bone marrow come from the patients himself/herself. With a conventional method and reagent,Ficoll, mononuclear cells were isolated with deleting erythrocyte by density gradient centrifugation.
Biologisk: autologous bone marrow mononuclear cells
Bone marrow was taken from patient oneself and mononuclear cells were isolated with deleting erythrocyte by density gradient centrifugation. Bone marrow mononuclear cells were transplanted into ischemia regions of lower limb through intramuscular injection.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Cell transplantation related side effect
Tidsramme: 2 week after cell transplantation
Temperature,pulse,respiration,blood pressure,routine analysis of blood and urine, liver function,renal function,function of coagulation, ECG,cell transplantation related death and cell transplantation related unexpected amputation
2 week after cell transplantation

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
ulcer size
Tidsramme: Post cell transplantation: 1, 3, 6 months
Measuring ulcer area (cm2) and depth (mm)of limb : For each ulcer , photographically record the area and depth with a ruler in order to calculate the ulcer area in square millimeters.
Post cell transplantation: 1, 3, 6 months
rest pain score
Tidsramme: Post cell transplantation: 1,3, 6 months

Scoring the rest pain based on the degree of pain as following five scales): 0 level-0 point: no pain;

  1. level-1 point: occasional pain which can be recalled;
  2. level-2 points: the pain often but can be tolerated, without or with a little analgesics;
  3. level-3 points: often with need of general analgesics;
  4. level -4 points: affect sleeping due to the pain, general pain medication being difficult to alleviate.

Before transplantation: points; after transplantation: points.
Post cell transplantation: 1,3, 6 months
cold sensation score
Tidsramme: Post cell transplantation: 1,3, 6 months

based on a sense of cold as following five scales: 0 level-0 point: no cold sensation;

  1. level-1 point, or : Occasionally cold feeling;
  2. level-2 points: Often with cold feeling;
  3. level-3 points: significantly cold feeling. and can be significantly improved when using a local insulation.
  4. level-4 points: significantly cold feeling,and can not be significantly improved when using a local insulation.
Post cell transplantation: 1,3, 6 months
Resting ABI
Tidsramme: Post cell transplantation: 1,3, 6 months
Measurement of ABI(ankle brachial index, ABI): Measure arterial pressure with a laser Doppler, and then calculate the ankle-brachial index, that is a ratio of ankle arterial blood pressure to brachial arterial blood pressure at rest.
Post cell transplantation: 1,3, 6 months
Resting TcPO2 (mmHg)
Tidsramme: Post cell transplantation:1, 3, 6 months
Transcutaneous oxygen pressure(TcPO2) should be measured at the same site in the ischemic limb at rest.
Post cell transplantation:1, 3, 6 months
Collateral vessel score
Tidsramme: Post cell transplantation: 1,3, 6 months

Collateral vessel score: Using computed tomographic angiography to score the collateral vessel formation. A mean score is obtained for each ischemic limb by 3 independent interventionists based on the following 4 level score: 0 (no new collateral vessels)

  1. (A little new collateral vessels)
  2. (moderate new collateral blood vessels)
  3. (Rich new collateral vessels)
Post cell transplantation: 1,3, 6 months
Skin microcirculation measurement
Tidsramme: 1,3,6 months post cell transplantation
using PeriMed "laser-Doppler flowmetry" measure the skin microcirculation on the same site in the ischemic limb at rest.
1,3,6 months post cell transplantation

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hebei Medical University

Efterforskere

  • Ledende efterforsker: Quanhai Li, doctor, The First Hospital of Hebei Medical University
  • Studieleder: Huimin Zhou, doctor, The First Hospital of Hebei Medical University
  • Ledende efterforsker: Xu Han, master, The First Hospital of Hebei Medical University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2012

Primær færdiggørelse (Faktiske)

1. september 2013

Studieafslutning (Forventet)

1. december 2014

Datoer for studieregistrering

Først indsendt

4. september 2013

Først indsendt, der opfyldte QC-kriterier

6. september 2013

Først opslået (Skøn)

9. september 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

4. december 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. december 2013

Sidst verificeret

1. december 2013

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 12276102D

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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