NCT01374854

Brief Summary

Umbilical mesenchymal stem cells (UC-MSCs) infusion is supposed be a promising regeneration therapy with mild side effect as indicated by large quantities of animal experiments and some clinical trials. There are few UC-MSCs clinical trials with regard to diabetes mellitus. The investigators hypothesize that infusion of USC-MSCs may provide multiple signals for beta-cell regeneration and even re-differentiate into local tissues in diabetes mellitus patients, resulting in improvement of diabetic control, of which the effect may be promoted by concomitant infusion of bone marrow mononuclear cells and maximized by intra-arterial pancreatic infusion through angiography.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2009

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 16, 2011

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

November 20, 2012

Status Verified

November 1, 2012

Enrollment Period

1.9 years

First QC Date

June 15, 2011

Last Update Submit

November 18, 2012

Conditions

Type 1 Diabetes Mellitus

Keywords

type 1 diabetes mellitusumbilical mesenchymal stem cellmononuclear cell

Outcome Measures

Primary Outcomes (1)

  • c-peptide area under the curve during OGTT

    1 year

Secondary Outcomes (6)

  • The incidence and severity of adverse events related to the stem cell infusion procedure

    1 year

  • The reduction in fasting blood glucose (FBG)

    1 year

  • The increase in basal C-peptide

    1 year

  • The reduction in exogenous insulin requirements

    1 year

  • Decrease in HbA1c

    1 year

  • +1 more secondary outcomes

Study Arms (2)

Stem Cell Infusion

EXPERIMENTAL
Biological: Umbilical mesenchymal stem cell (UC-MSCs) infusion

traditional therapy control

ACTIVE COMPARATOR
Drug: traditional therapy

Interventions

Umbilical mesenchymal stem cell (UC-MSCs) infusionBIOLOGICAL

1×10\^6/kg UC-MSCs is infused through pancreatic artery along with mononuclear cells by interventional therapy and another same dose of UC-MSCs is administered one week post-intervention.

Stem Cell Infusion
traditional therapyDRUG

exogenous insulin injection daily

traditional therapy control

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male and female patients age 18 to 65 years of age.
  • Ability to provide written informed consent.
  • Mentally stable and able to comply with the procedures of the study protocol.
  • Clinical history compatible with type 1 diabetes (T1DM) as defined by the Expert Committee on the Diagnosis and classification of Diabetes Mellitus
  • Onset of T1DM disease at ≤ 35 years of age.
  • T1DM duration ≥ 2 and ≤ 20 years at the time of enrollment.
  • Basal C-peptide ≤ 0.3 ng/mL
  • HbA1c ≥ 7.5 at time of enrollment.

You may not qualify if:

  • BMI \>35 kg/m\^2.
  • Insulin requirements of \> 100 U/day.
  • C-reactive protein (hs-CRP) \>3.00ng/ml
  • Uncontrolled blood Pressure: SBP \>160 mmHg or DBP \>100 mmHg at the time of enrollment.
  • Evidence of renal dysfunction, serum creatinine \> 1.5 mg/dl (males) and 1.4 mg/dl (females).
  • Proteinuria \> 300 mg/day
  • Evidence of cardiovascular disease, existing congestive cardiac failure on physical exam and/or acute coronary syndrome in past 6 months.
  • For female participants: Positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study. For male participants: intent to procreate 3 months before or after the intervention or unwillingness to use effective measures of contraception. Oral contraceptives, Norplant®, Depo-Provera®, and barrier devices with spermicide are acceptable contraceptive methods; condoms used alone are not acceptable
  • Active infection including hepatitis C, HIV, or TB as determined by a positive skin test or clinical presentation, or under treatment for suspected TB. Positive tests are acceptable only if associated with a history of previous vaccination in the absence of any sign of active infection. Positive tests are otherwise not acceptable, even in the absence of any active infection at the time of evaluation
  • Known active alcohol or substance abuse including cigarette/cigar smoking
  • Baseline Hemoglobin below the lower limits of normal at the local laboratory; lymphopenia (\<1,000/L), neutropenia (\<1,500/L), or thrombocytopenia (platelets \<100,000/L).
  • A history of Factor V deficiency or other coagulopathy defined by INR \>1.5, PTT \>40, PT \>15.
  • Any coagulopathy or medical condition requiring long-term anticoagulant therapy (e.g., warfarin) after transplantation (low-dose aspirin treatment is allowed) or patients with an INR \>1.5.
  • Acute or chronic pancreatitis.
  • Symptomatic peptic ulcer disease.
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuzhou General Hospital

Fuzhou, Fujian, 350025, China

Location

Related Publications (2)

  • Wu Z, Xu X, Cai J, Chen J, Huang L, Wu W, Pugliese A, Li S, Ricordi C, Tan J. Prevention of chronic diabetic complications in type 1 diabetes by co-transplantation of umbilical cord mesenchymal stromal cells and autologous bone marrow: a pilot randomized controlled open-label clinical study with 8-year follow-up. Cytotherapy. 2022 Apr;24(4):421-427. doi: 10.1016/j.jcyt.2021.09.015. Epub 2022 Jan 25.

    PMID: 35086778DERIVED

  • Cai J, Wu Z, Xu X, Liao L, Chen J, Huang L, Wu W, Luo F, Wu C, Pugliese A, Pileggi A, Ricordi C, Tan J. Umbilical Cord Mesenchymal Stromal Cell With Autologous Bone Marrow Cell Transplantation in Established Type 1 Diabetes: A Pilot Randomized Controlled Open-Label Clinical Study to Assess Safety and Impact on Insulin Secretion. Diabetes Care. 2016 Jan;39(1):149-57. doi: 10.2337/dc15-0171. Epub 2015 Dec 1.

    PMID: 26628416DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Jianming Tan, professor

    Fuzhou General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2011

First Posted

June 16, 2011

Study Start

January 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2014

Last Updated

November 20, 2012

Record last verified: 2012-11

Locations

CN(1)