Diabetes Mellitus Type 1Phase 1NCT02940418
Use of Stem Cells in Diabetes Mellitus Type 1
A Phase 1 study testing Adipose mesenchymal cells with bone marrow mononuclear cells in people with Diabetes Mellitus Type 1, run by Sophia Al-Adwan at 1 site in Jordan.
Trial summary
Allogenic adipose derived mesenchymal stem cells will be injected into patients newly diagnosed with type 1 Diabetes Mellitus Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Diabetes Mellitus Type 1
- What is being tested?
- Adipose mesenchymal cells with bone marrow mononuclear cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteJordan
- Study dates
- 19 Feb 2017to Jan 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult Patients with Type 1 Diabetes Mellitus.
- Age from 18 years to 35 years either gender.
- Duration of disease: not exceeding 3 years unless C-peptide is not less than 0.5 ng/ml
- C-Peptide at inclusion base line should not be less than 0.5 ng/ml
- No clinical evidence of renal, retinal, vascular or skin complications
- Body Mass Index not exceeding 30
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- Any HbA1c
- At least one positive antibody either anti-Glutamic Acid Decarboxylase-65 or Insulinoma-Associated-2 Autoantibodies (anti-1A2)
- Informed Consent by patient
Who cannot join
- Age less than 18 years and more than 35 years
- Pregnancy
- Married women or women expected to be married within the study period
- History of allergy, Cancer, bronchial asthma, liver disease or hepatitis
- Diabetic coma or pre-coma current or recent within the last 2 months
- C-Peptide less than 0.5 ng/ml
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- Disease duration more than 3 yrs.
- Complication mentioned in 5 above in inclusion
- Non-consenting patient or withdrawal of consent.
- Bleeding disorders
Trial locations and contacts
1 site in 1 country.
Jordan1 site, 1 recruiting
- Recruiting
Cell Therapy Center
Amman, 11942
Abdalla Awidi, MD, 0096265355000 ext. 23960, abdalla.awidi@gmail.com
About this study
Official title: The Use of Mesenchymal Stromal Cells (MSC) in Type 1 Diabetes Mellitus in Adult Humans: Phase I Clinical Trial
Allogenic adipose derived mesenchymal stem cells will be injected into patients newly diagnosed with type 1 Diabetes Mellitus
Read the 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.
- Conditions
- Diabetes Mellitus Type 1
- Being tested
- Adipose mesenchymal cells with bone marrow mononuclear cells
- Keywords
- Diabetes Mellitus, Type 1, Adipose derived mesenchymal stem cells
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adipose mesenchymal cells with bone marrow mononuclear cellsBiological
Allogenic adipose-derived mesenchymal cells with autologous bone marrow mononuclear cells will be injected.
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 mil/kg | Active comparator | 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. Receives: Biological: Adipose mesenchymal cells with bone marrow mononuclear cells |
| Dose 10 mil/kg | Active comparator | 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. Receives: Biological: Adipose mesenchymal cells with bone marrow mononuclear cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of using allogenic ASC assessed by any adverse events
Patients will be assessed for any adverse events as a result of the injection.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2016 (estimated)
- Study start19 Feb 2017
- Primary completionNov 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sophia Al-Adwan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sophia Al-Adwan, University of Jordan
- Investigators
- Abdallah Awidi, MD, Study director, Cell Therapy Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02940418
- Sponsor's protocol ID
- T1DM.UJCTC
- Status last verified
- Jul 2019
- First submitted
- 19 Oct 2016
- Last updated
- 24 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Mesenchymal Stromal Cells (MSC) in Type 1 Diabetes Mellitus in Adult Humans: Phase I Clinical Trial
- ClinicalTrials.gov ID
- NCT02940418
- Acronym / sponsor ID
- T1DM.UJCTC
- Conditions
- Diabetes Mellitus Type 1
- Keywords
- Diabetes Mellitus, Type 1, Adipose derived mesenchymal stem cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sophia Al-AdwanUniversity, hospital or other
- Study start
- 19 Feb 2017 (actual)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 20 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Allogenic adipose derived mesenchymal stem cells will be injected into patients newly diagnosed with type 1 Diabetes Mellitus
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose 1 mil/kg | Active comparator | Biological: Adipose mesenchymal cells with bone marrow mononuclear cellsAdipose 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. |
| Dose 10 mil/kg | Active comparator | Biological: Adipose mesenchymal cells with bone marrow mononuclear cellsAdipose 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Adult Patients with Type 1 Diabetes Mellitus.
- Age from 18 years to 35 years either gender.
- Duration of disease: not exceeding 3 years unless C-peptide is not less than 0.5 ng/ml
- C-Peptide at inclusion base line should not be less than 0.5 ng/ml
- No clinical evidence of renal, retinal, vascular or skin complications
Key exclusion criteria (10 listed)
- Age less than 18 years and more than 35 years
- Pregnancy
- Married women or women expected to be married within the study period
- History of allergy, Cancer, bronchial asthma, liver disease or hepatitis
- Diabetic coma or pre-coma current or recent within the last 2 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adipose mesenchymal cells with bone marrow mononuclear cellsAllogenic adipose-derived mesenchymal cells with autologous bone marrow mononuclear cells will be injected. | Biological | Dose 1 mil/kg, Dose 10 mil/kg |
Primary outcome
Safety of using allogenic ASC assessed by any adverse events
Time frame: 6 months
Patients will be assessed for any adverse events as a result of the injection.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdallah Awidi, MD study director
Cell Therapy Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Adipose mesenchymal cells with bone marrow mononuclear cells in people with Diabetes Mellitus Type 1, run by Sophia Al-Adwan at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hanan D. Jafar, PhD (00962798871087, hanan.jafar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of using allogenic ASC assessed by any adverse events (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2019.