Efficacy Of Autologous Bone Marrow Derived Stem Cell Transplantation In Patients With Type 2 Diabetes Mellitus-2
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Postgraduate Institute of Medical Education and Research.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Postgraduate Institute of Medical Education and Research
Information provided by:
Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier:
NCT01065298
First received: February 8, 2010
Last updated: February 10, 2010
Last verified: November 2009
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Purpose
The purpose of this study is to improve blood glucose control in Type 2 Diabetes mellitus patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus |
Biological: stem cell transplantation |
Phase 2 Phase 3 |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Efficacy Of Autologous Bone Marrow Derived Stem Cell Transplantation In Patients With Type 2 Diabetes Mellitus |
Resource links provided by NLM:
Further study details as provided by Postgraduate Institute of Medical Education and Research:
Primary Outcome Measures:
- Reduction of insulin requirement by ≥ 50% by the end of 6 months of ABMSCT and Improvement in Glucagon stimulated C - peptide levels . [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Any reduction in requirement of insulin dosage and any improvement of HbA1c levels as compared to controls. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | July 2011 |
| Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Group 1:Stem cell Recipient
Patients with Type 2 Diabetes mellitus on full doses of Vildagliptin+Pioglitazone+Metformin and requiring Insulin at dose of >0.4U/Kg for blood glucose control. They will undergo stem cell therapy initialy and G-CSF therapy at 2 months
|
Biological: stem cell transplantation
Group 1: 200 - 250 ml of bone marrow will be aspirated and layered on density gradient medium (Ficoll - Hyperaque) and stem cells will be separated. Separated MNC's will be tagged with FDG-PET and injected into superior pancreatico duodenal artery and an PET scan will be done 2 hours later to see the percentage of stem cells homing in to pancreas. After 8 weeks G-CSF(10mcg/Kg/day) will be given subcutaneous for 5 days to achieve a Leucocyte count of >40,000/mm3. Patients will be urged to monitor and document blood glucose readings for next 6 months. Glucagon stimulated C - peptide, plasma Insulin, HOMA-IR , HOMA-B ,HbA1c, lipid profile and biochemistry will be done at baseline and 6 months .
Other Name: Autologous Bone marrow derived stem cell transplantation
|
|
Group-2: Controls
Type 2 Diabetes mellitus patients on full doses of vildagliptin+metformin+pioglitazone and on Insulin >0.4U/Kg who will act as active control.They will receive injectable placebo at Day 1 in addition to above and will be followed up for 6 months.Follow up investigation and Insulin dose titration will be similar to Group 1.
|
Detailed Description:
We hypothesize that Autologous bone marrow derived stem cell transplantation(ABMSCT)into the pancreas of patients with T2DM, aged 30 - 70 years with triple oral hypoglycemic agent failure and on insulin(>0.4 U/ kg body weight/day) will lead to abolition or reduction of insulin requirement by more than or equal to 50% in these patients over a period of 6 months. It is assumed that ABMSCT in these patients leads to increased angiogenesis, secretion of various cytokines and upregulation of pancreatic transcription factors and Vascular endothelial growth factor(VEGF) and creates a microenvironment which supports beta cell/resident stem cell activation and survival.
Eligibility| Ages Eligible for Study: | 30 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Patients with type 2 Diabetes mellitus with triple Oral hypoglycemic failure and on Insulin for glycemic control
Criteria
Inclusion Criteria:
- Patients with type 2 diabetes mellitus between 30 and 70 years of age.
- Failure to triple OHA and on stable doses of insulin for atleast 3 months.
- On vildagliptin,pioglitazone and metformin for atleast 3 months along with Insulin to maintain euglycemia.
- HbA1c < 8.5%.
- Insulin requirement ≥0.4 IU/kg/d.
- GAD antibody negative status.
Exclusion Criteria:
- Patients with T1DM or secondary diabetes.
- Patients with serum creatinine > 1.5 mg/dl.
- Abnormal liver function tests (defined as value of transaminases > 3 times the upper value of normal or serum bilirubin higher than normal for the reference value for the laboratory).
- History of cholecystitis/ cholelitiasis/ cholecystectomy
- Seropositivity for HIV, HBsAg and HCV.
- History of myocardial infarction or unstable angina in the previous 3 months.
- History of malignancy
- Patients with active infections.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01065298
Contacts
| Contact: Anil Bhansali, MD.,DM | 2756583 ext 0172 | anilbhansali_endocrine@rediffmail.com |
| Contact: Prem kumar, MD | 09872308780 | prem.kkumar@rediffmail.com |
Locations
| India | |
| Post Graduate Institute of Medical Education and Research | Recruiting |
| Chandigarh, Chandigarh UT, India | |
| Principal Investigator: Prem Kumar, MD | |
| Sub-Investigator: Shobhit Bhansali, Msc | |
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Investigators
| Study Chair: | Anil Bhansali, MD.,DM | Postgraduate Institute of Medical Education and Research |
| Principal Investigator: | Neelam Marwaha, MD.,DM | Postgraduate Institute of Medical Education and Research |
| Principal Investigator: | N Khandelwal, MD | Postgraduate Institute of Medical Education and Research |
| Principal Investigator: | B.R. Mittal, MD | Postgraduate Institute of Medical Education and Research |
| Principal Investigator: | Prem Kumar, MD | Postgraduate Institute of Medical Education and Research |
| Principal Investigator: | Rama Walia, MD.,DM | Postgraduate Institute of Medical Education and Research |
More Information
Publications:
| Responsible Party: | Anil Bhansali, PIMERindia |
| ClinicalTrials.gov Identifier: | NCT01065298 History of Changes |
| Other Study ID Numbers: | ABMSCT2 |
| Study First Received: | February 8, 2010 |
| Last Updated: | February 10, 2010 |
| Health Authority: | India: Indian Council of Medical Research |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013