MSC and MC in Type 2 Diabetes Mellitus

NCT01719640 | Completed Phase 1 DMC

• 1 other identifier: MSC-MC-DM
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Cell injury in human islets induced by non-immune mediated inflammation occur in vitro upon hyperglycemia in type 2 diabetes mellitus. Infusion of autologous bone marrow mononuclear cells (MCs) is an emerging therapeutic approach for DM, which showed promising outcomes with mild side effects. Infusion of MCs and autologous bone marrow mesenchymal stem cells in combination might exert enhanced repairing effects. We hypothesized that infusion of these two classes of cells might provide multiple signals for regeneration and improve recovery from inflammation-induced lesion. The effects might be maximized by intra-arterial pancreatic infusion.

Conditions

Diabetes Mellitus, Type 2

Keywords

mesenchymal stem cells; bone marrow mononeclear cells; type 2 diabetes mellitus

Outcome Measures

Primary Outcomes (2)

• macrovascular complications

  8 years

• microvascular complications

  8 years

Secondary Outcomes (15)

• DPN

  8 years

• MI

  8 years

• angina

  8 years

• stroke

  8 years

• amputation

  8 years

Study Arms (3)

MSC+MC

EXPERIMENTAL

infusion of BMMSC+BMMNC and insulin injection

Drug: infusion of MSCs; Drug: infusion MCs; Drug: insulin

MC

ACTIVE COMPARATOR

infusion of BMMNC and insulin injection

Drug: infusion MCs; Drug: insulin

Insulin

ACTIVE COMPARATOR

insulin injection

Drug: insulin

Interventions

infusion of MSCs DRUG

infusion of MSCs

MSC+MC

infusion MCs DRUG

infusion of MCs

MC; MSC+MC

insulin DRUG

intensive insulin care

Insulin; MC; MSC+MC

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to provide written informed consent.
• Mentally stable and able to comply with the procedures of the study protocol.
• Clinical history compatible with type 2 diabetes (T2DM) as defined by the Expert Committee on the Diagnosis and classification of Diabetes Mellitus
• Onset of T2DM disease at ≥ 35 years of age.
• T2DM duration ≥ 3 and ≤ 20 years at the time of enrollment.
• Basal C-peptide 0.3-2.0 ng/mL
• HbA1c ≥ 7.5 and ≤ 12% before standard medical therapy (SMT). Patients must have been treated with SMT for minimum of 4 months prior to randomization.
• Insulin dose and metformin doses should be stable over the 3 months prior to randomization.
• HbA1c ≥ 7.5 and ≤ 9.5% at time of randomization.
• Total insulin daily dose (TDD) at time of randomization should not exceed 1.0 units/day/kg

You may not qualify if:

• BMI \>35 kg/m2.
• Insulin requirements of \> 100 U/day.
• HbA1c \>9.5%. (at the time of randomization)
• C-reactive protein (hs-CRP) \>3.00
• Uncontrolled blood Pressure: SBP \>160 mmHg or DBP \>100 mmHg at the time of randomization.
• 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 Hgb 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.

Sponsors & Collaborators

• Fuzhou General Hospital: lead

Study Sites (1)

Fuzhou General Hospital, Xiamen Univ

Fuzhou, Fujian, 350025, China

Location

Related Publications (1)

• Wu Z, Huang S, Li S, Cai J, Huang L, Wu W, Chen J, Tan J. Bone marrow mesenchymal stem cell and mononuclear cell combination therapy in patients with type 2 diabetes mellitus: a randomized controlled study with 8-year follow-up. Stem Cell Res Ther. 2024 Sep 30;15(1):339. doi: 10.1186/s13287-024-03907-w.

  PMID: 39350270 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 6, 2012
• First Posted: November 1, 2012
• Study Start: January 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2020
• Last Updated: January 12, 2023

Record last verified: 2023-01

Locations

CN (1)