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DiabetesPhase 1NCT01937416

Autologous Bone Marrow Mononuclear Cells Therapy in Diabetic Lower Limb Ischemia

A Phase 1 study testing autologous bone marrow mononuclear cells in people with Diabetes and Lower Limb Ischemia, run by Hebei Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Diabetes, Lower Limb Ischemia
What is being tested?
autologous bone marrow mononuclear cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteChina
Study dates
Jan 2012to Dec 2014
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • the First Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000

    Xu Han, master, 86-311-85917202, hanxu98@126.com

    Recruiting

Other trials in China

About this study

Official title: 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.

Read the detailed description

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.

Being tested
autologous bone marrow mononuclear cells
Medical subject headings
Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • autologous bone marrow mononuclear cellsBiological

    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.

Study groups in NCT01937416
Study groupRoleWhat they receive
autologous bone marrow mononuclear cellsExperimentalBone 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.
Receives: Biological: autologous bone marrow mononuclear cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cell transplantation related side effect

    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

    Measured: 2 week after cell transplantation

Secondary outcomes (7)

  1. ulcer size

    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.

    Measured: Post cell transplantation: 1, 3, 6 months

  2. rest pain score

    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.

    Measured: Post cell transplantation: 1,3, 6 months

  3. cold sensation score

    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.

    Measured: Post cell transplantation: 1,3, 6 months

  4. Resting ABI

    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.

    Measured: Post cell transplantation: 1,3, 6 months

  5. Resting TcPO2 (mmHg)

    Transcutaneous oxygen pressure(TcPO2) should be measured at the same site in the ischemic limb at rest.

    Measured: Post cell transplantation:1, 3, 6 months

  6. Collateral vessel score

    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)

    Measured: Post cell transplantation: 1,3, 6 months

  7. Skin microcirculation measurement

    using PeriMed "laser-Doppler flowmetry" measure the skin microcirculation on the same site in the ischemic limb at rest.

    Measured: 1,3,6 months post cell transplantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2013 (estimated)
  2. Study startJan 2012
  3. Primary completionSep 2013
  4. Study completionDec 2014 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01937416
Sponsor's protocol ID
12276102D
Status last verified
Dec 2013
First submitted
4 Sep 2013
Last updated
4 Dec 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing autologous bone marrow mononuclear cells in people with Diabetes and Lower Limb Ischemia, run by Hebei Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cell transplantation related side effect (time frame: 2 week after cell transplantation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01937416.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2013.

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