Use of Stem Cells in Diabetes Mellitus Type 1

• Sponsor: Sophia Al-Adwan (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02940418
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 34.4
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

Allogenic adipose derived mesenchymal stem cells will be injected into patients newly diagnosed with type 1 Diabetes Mellitus

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus Type 1	Biological: Adipose mesenchymal cells with bone marrow mononuclear cells	Phase 1

Detailed Description

Adipose derived mesenchymal stem cells (ASCs) are to be collected from blood group O donor, cells will be passaged to passage 5.

Before release the sample will be subject to our release criteria which include: testing for any bacterial or fungal growth as well as endotoxin and mycoplasma. All these tests must be negative. In addition the cell count and viability (must be more than 80%) are done before release. Surface markers documentation is done on the cells before release using flow cytometry.

The cells should be infused within 2 hours of release. The dose to is to be repeated after 6 months of a total of two doses in patients. Tests and follow up are to be one at week 12, 24 and 36 when the study is stopped.

These cells will be injected intravenously into patients newly diagnosed with type 1 Diabetes Mellitus.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Use of Mesenchymal Stromal Cells (MSC) in Type 1 Diabetes Mellitus in Adult Humans: Phase I Clinical Trial
• Actual Study Start Date: Feb 19, 2017
• Anticipated Primary Completion Date: Nov 1, 2019
• Anticipated Study Completion Date: Jan 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Dose 1 mil/kg Adipose mesenchymal cells with bone marrow mononuclear cells. Two doses with a 6 month interval of allogenic Adipose mesenchymal cells +1 mil/kg of autologous bone marrow mononuclear cells will be injected intravenously.	Biological: Adipose mesenchymal cells with bone marrow mononuclear cells; Allogenic adipose-derived mesenchymal cells with autologous bone marrow mononuclear cells will be injected.
Active Comparator: Dose 10 mil/kg Adipose mesenchymal cells with bone marrow mononuclear cells. Two doses with a 6 month interval of allogenic Adipose mesenchymal cells +10 mil/kg of autologous bone marrow mononuclear cells will be injected intravenously.	Biological: Adipose mesenchymal cells with bone marrow mononuclear cells; Allogenic adipose-derived mesenchymal cells with autologous bone marrow mononuclear cells will be injected.

Outcome Measures

Primary Outcome Measures

1. Safety of using allogenic ASC assessed by any adverse events [6 months]

   Patients will be assessed for any adverse events as a result of the injection.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Adult Patients with Type 1 Diabetes Mellitus.

2. Age from 18 years to 35 years either gender.

3. Duration of disease: not exceeding 3 years unless C-peptide is not less than 0.5 ng/ml

4. C-Peptide at inclusion base line should not be less than 0.5 ng/ml

5. No clinical evidence of renal, retinal, vascular or skin complications

6. Body Mass Index not exceeding 30

7. Any HbA1c

8. At least one positive antibody either anti-Glutamic Acid Decarboxylase-65 or Insulinoma-Associated-2 Autoantibodies (anti-1A2)

9. Informed Consent by patient

Exclusion Criteria:

1. Age less than 18 years and more than 35 years

2. Pregnancy

3. Married women or women expected to be married within the study period

4. History of allergy, Cancer, bronchial asthma, liver disease or hepatitis

5. Diabetic coma or pre-coma current or recent within the last 2 months

6. C-Peptide less than 0.5 ng/ml

7. Disease duration more than 3 yrs.

8. Complication mentioned in 5 above in inclusion

9. Non-consenting patient or withdrawal of consent.

10. Bleeding disorders

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cell Therapy Center	Amman		Jordan	11942

Sponsors and Collaborators

• Sophia Al-Adwan

Investigators

• Study Director: Abdallah Awidi, MD, Cell Therapy Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sophia Al-Adwan, Biologist, PhD, University of Jordan
• ClinicalTrials.gov Identifier: NCT02940418
• Other Study ID Numbers: T1DM.UJCTC
• First Posted: Oct 20, 2016
• Last Update Posted: Jul 24, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Sophia Al-Adwan, Biologist, PhD, University of Jordan: Diabetes Mellitus; Type 1; Adipose derived mesenchymal stem cells
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1

Study Results

No Results Posted as of Jul 24, 2019