Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered in Patients With Type II Diabetes

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01453751
• Date of registration: 03/10/2011
• Primary sponsor: Ageless Regenerative Institute
• Public title: Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered in Patients With Type II Diabetes
• Scientific title: An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered Via Catheter Into the Pancreatic Artery and/or Intravenously in Patients With Type II Diabetes
• Date of first enrolment: May 2011
• Target sample size: 10
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01453751
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Mexico

Contacts

• Name: Jesus A Perez, MD

• Name: Janny Garcia, Biomedical Engineer

• Name: Rigoberto Pallares, MD
• Affiliation: Instituto de Medicina Regenerativa

Key inclusion & exclusion criteria

Inclusion Criteria:

- Males and Females between Age 18 and 80 years.

- Type 2 diabetes mellitus (as guideline WHO, 1999);

- Body mass index (BMI)=35?/?;

- Fast blood glucose (FBG)=7.0 mmol/L, and Hemoglobin A1c (HgbA1c)=7%;

- Up to date on all age and gender appropriate cancer screening per American Cancer
Society.

Exclusion Criteria:

- Females who are pregnant or nursing or females of childbearing potential who are
unwilling to maintain contraceptive therapy for the duration of the study

- Life expectancy < 6 months due to concomitant illnesses.

- Exposure to any investigational drug or procedure within 1 month prior to study entry
or enrolled in a concurrent study that may confound results of this study.

- Active infectious disease. If patients have tested positive, they will be consulted
as to patient eligibility based on the patient's infectious status

- Any illness which, in the Investigator's judgment, will interfere with the patient's
ability to comply with the protocol, compromise patient safety, or interfere with the
interpretation of the study results

- Patients on chronic immunosuppressive transplant therapy

- Systolic blood pressure (supine) =90 mmHg or >180mmHg

- Resting heart rate > 100 bpm;

- Active clinical infection within one week of enrollment.

- Known drug or alcohol dependence or any other factors which will interfere with the
study conduct or interpretation of the results or who in the opinion of the
investigator are not suitable to participate.

- History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in
the last five years.

- Unwilling and/or not able to give written informed consent.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetes Mellitus Type II

Intervention(s)

Procedure: Harvesting and Implantation of Adipose-Derived Stem Cells (ASCs)

Procedure: Harvesting and Implantation of Stem Cells

Primary Outcome(s)

Reduction of insulin requirement by > 50% [Time Frame: 3 months]

Reduction of insulin requirement by > 50% [Time Frame: 6 months]

safety of adipose-derived stem cell injection [Time Frame: up to the 6-month period following treatment]

Secondary Outcome(s)

Improvement of HbA1c levels as compared to baseline [Time Frame: 6 months]

Improvement of Hemoglobin A1c(HbA1c) levels as compared to baseline [Time Frame: 3 months]

reduction in requirement of insulin dosage [Time Frame: 6 months]

reduction in requirement of insulin dosage compared to baseline [Time Frame: 3 months]

Secondary ID(s)

ADI-DI-ME-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Instituto de Medicina Regenerativa, S.A. de C.V.