Stem CellsPhase 2/3NCT06951074
Insulin Producing Stem Cell Transplantation Clinical Trial in Type 1 Diabetes
A Phase 2/3 study testing Insulin producing stem cells infusion in people with Stem Cells and Type 1 Diabetes, run by Ain Shams University at 1 site in Egypt.
Trial summary
Type 1 Diabetes is a chronic autoimmune disease. It results from autoimmune destruction of pancreatic Beta cells leading to absolute insulin insufficiency. The establishment of pluripotent like human stem cells derived from adipose tissue derived mesenchymal cell origin have introduced a new potential source for cell… Read more about this study
- Who is it for?
- Ages 15 to 18 years
- Conditions the study is for
- Stem Cells, Type 1 Diabetes
- What is being tested?
- Insulin producing stem cells infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2025to 1 Sep 2026
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 15 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Type 1 diabetes
Who cannot join
- patients with other autoimmune diseases
- patients with micro or macro vascular complications
- patients with other chronic diseases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Children Hospital Eldemerdash
Cairo
Rasha Eladawy Shaaban Elmetwally, MD, 20201092143033, dr.rashaeladawy@med.asu.edu.eg
About this study
Official title: Autologous Insulin Producing Mesenchymal Stem Cell Transplantation in Youth With Type 1 Diabetes
Type 1 Diabetes is a chronic autoimmune disease. It results from autoimmune destruction of pancreatic Beta cells leading to absolute insulin insufficiency. The establishment of pluripotent like human stem cells derived from adipose tissue derived mesenchymal cell origin have introduced a new potential source for cell therapy in type 1 diabetic patients, especially in light of recent successes in producing glucose-sensitive insulin secreting cells and this will be the scope of this study. In the last decade, human clinical trials of introducing insulin producing stem cells from various origins were approved and conducted.
Read the detailed description
Differentiation of stem cells from various sources to form insulin-producing cells (IPCS) provides a new and promising strategy to reconstitute pancreatic endocrine function. Studies recently developed a multistep differentiation technique for the differentiation of human embryonic stem cells to form pancreatic progenitors. At the end of in vitro differentiation approximately 5% of cells became insulin positive.
Mesenchymal stem cells (MSCs) can be derived from various sources. MSCs are undifferentiated cells with multilinear potential, known for their immunomodulatory and regenerative properties . The bone marrow, adipose tissue, umbilical cord, liver cells, and endometrium are among several tissues that are rich in MSCs. Of these, the bone marrow and adipose tissues offer distinct advantages in view of their availability and abundance and the extent of their documentation.
In this study the investigators aim to obtain autologous differentiated insulin producing mesenchymal stem cells (derived from adipose tissue) and their introduction in human subjects with type 1 diabetes. The current study will assess of the ability of the transplanted cells to produce insulin both in vitro and in vivo. Post- transplant glycemic control will be assessed with possible amelioration of the standard treatment of type 1 diabetes.
- Conditions
- Stem Cells, Type 1 Diabetes
- Being tested
- Insulin producing stem cells infusion
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin producing stem cells infusionBiological
- Liposuction of the anterior abdominal subcutaneous fat layer of participant
- Characterization and Identification of mesenchymal stem cells
- Differentiation of mesenchymal stem cells into insulin producing stem cells
- In vitro detection of Insulin and c-peptide in differentiated MSC (Confirmatory tests for the insulin producing cells)
- In vitro Insulin and c-peptide release detection in differentiated MSC in response to increasing glucose concentrations Differentiated MSCs injection in human subjects
- Followup
| Study group | Role | What they receive |
|---|---|---|
| group 1a IPSC transplant in portal circulation | Experimental | Insulin producing stem cells injection in portal circulation Receives: Biological: Insulin producing stem cells infusion |
| group 1b IPSC in peripheral systemic circulation | Experimental | Insulin producing stem cells injection in peripheral systemic circulation Receives: Biological: Insulin producing stem cells infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin producing mesenchymal stem cells efficacy in insulin production in vitro
Assessment of the percentage of mature insulin and c peptide production in insulin producing stem cells.
Measured: 1 year
Insulin producing mesenchymal stem cells efficacy in insulin production in vitro
Assestment of percentage of mature insulin production and c peptide in insulin producing stem cells in response to different concentrations of glucose.
Measured: 1 year
Insulin producing mesenchymal stem cells efficacy in insulin production in vivo
Participants glycemic control will be assesed before and after insulin producing stem cells injection.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start1 Apr 2025
- Primary completion1 May 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Stem CellsStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Twenty youth with T1D, aged 15 to 18 years will participate in this clinical trial. The International Society for Pediatric and Adolescent Diabetes (ISPAD) guidelines for Type 1 diabetes diagnosis (2024) will be used to confirm the diagnosis of Type 1 Diabetes. Patients' group will be subsequently separated into two subgroups 1a and 1b, each of which contain 10 patients. Group 1a will represent patients who will receive the insulin producing MScs through the portal circulation via Ultrasound guided portal vein injection. Group 1b will represent the patients who will receive the insulin producing MScs through the systemic circulation via peripheral cannulation. The Pediatrics and Adolescent Diabetic Clinic at Ain Shams University Hospital will be used to enroll T1D participants. Patients involved in the study will be admitted in the Pediatric Hospital (El-Demerdash)
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rasha S Elmetwally, A. Prof, Principal investigator, Assistant professor of Pediatrics, Faculty of Medicine, Ain Shams UniversityRanda M Matter, Prof, Study director, Professor of pediatrics, Faculty of Medicine, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06951074
- Sponsor's protocol ID
- AinShamsPedDiabetes
- Status last verified
- Jan 2025
- First submitted
- 4 Apr 2025
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abou Zaki R, El-Osta A. Advancing type 1 diabetes therapy: autologous islet transplant breakthrough. Signal Transduct Target Ther. 2024 Dec 23;9(1):366. doi: 10.1038/s41392-024-02090-x. No abstract available.
PubMed 39710778Ulyanova O, Askarov M, Kozina L, Karibekov T, Shaimardanova G, Zhakupova A, Danilova D, Serebrennikova D. Autologous Mesenchymal Stem Cell Transplant in Patients with Type 1 Diabetes Mellitus. Exp Clin Transplant. 2019 Jan;17(Suppl 1):236-238. doi: 10.6002/ect.MESOT2018.P100.
PubMed 30777564Jayasinghe M, Prathiraja O, Perera PB, Jena R, Silva MS, Weerawarna PSH, Singhal M, Kayani AMA, Karnakoti S, Jain S. The Role of Mesenchymal Stem Cells in the Treatment of Type 1 Diabetes. Cureus. 2022 Jul 27;14(7):e27337. doi: 10.7759/cureus.27337. eCollection 2022 Jul.
PubMed 36042996
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Insulin Producing Mesenchymal Stem Cell Transplantation in Youth With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT06951074
- Acronym / sponsor ID
- AinShamsPedDiabetes
- Conditions
- Stem Cells, Type 1 Diabetes
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 30 Apr 2025 (actual)
- 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.
Type 1 Diabetes is a chronic autoimmune disease. It results from autoimmune destruction of pancreatic Beta cells leading to absolute insulin insufficiency. The establishment of pluripotent like human stem cells derived from adipose tissue derived mesenchymal cell origin have introduced a new potential source for cell therapy in type 1 diabetic patients, especially in light of recent successes in producing glucose-sensitive insulin secreting cells and this will be the scope of this study. In the last decade, human clinical trials of introducing insulin producing stem cells from various origins were approved and conducted.
Detailed description
Differentiation of stem cells from various sources to form insulin-producing cells (IPCS) provides a new and promising strategy to reconstitute pancreatic endocrine function. Studies recently developed a multistep differentiation technique for the differentiation of human embryonic stem cells to form pancreatic progenitors. At the end of in vitro differentiation approximately 5% of cells became insulin positive.
Mesenchymal stem cells (MSCs) can be derived from various sources. MSCs are undifferentiated cells with multilinear potential, known for their immunomodulatory and regenerative properties . The bone marrow, adipose tissue, umbilical cord, liver cells, and endometrium are among several tissues that are rich in MSCs. Of these, the bone marrow and adipose tissues offer distinct advantages in view of their availability and abundance and the extent of their documentation.
In this study the investigators aim to obtain autologous differentiated insulin producing mesenchymal stem cells (derived from adipose tissue) and their introduction in human subjects with type 1 diabetes. The current study will assess of the ability of the transplanted cells to produce insulin both in vitro and in vivo. Post- transplant glycemic control will be assessed with possible amelioration of the standard treatment of type 1 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Twenty youth with T1D, aged 15 to 18 years will participate in this clinical trial. The International Society for Pediatric and Adolescent Diabetes (ISPAD) guidelines for Type 1 diabetes diagnosis (2024) will be used to confirm the diagnosis of Type 1 Diabetes. Patients' group will be subsequently separated into two subgroups 1a and 1b, each of which contain 10 patients. Group 1a will represent patients who will receive the insulin producing MScs through the portal circulation via Ultrasound guided portal vein injection. Group 1b will represent the patients who will receive the insulin producing MScs through the systemic circulation via peripheral cannulation. The Pediatrics and Adolescent Diabetic Clinic at Ain Shams University Hospital will be used to enroll T1D participants. Patients involved in the study will be admitted in the Pediatric Hospital (El-Demerdash)
| Arm | Type | Receives |
|---|---|---|
| group 1a IPSC transplant in portal circulation | Experimental | Biological: Insulin producing stem cells infusionInsulin producing stem cells injection in portal circulation |
| group 1b IPSC in peripheral systemic circulation | Experimental | Biological: Insulin producing stem cells infusionInsulin producing stem cells injection in peripheral systemic circulation |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Type 1 diabetes
Key exclusion criteria (3 listed)
- patients with other autoimmune diseases
- patients with micro or macro vascular complications
- patients with other chronic diseases
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 |
|---|---|---|
| Insulin producing stem cells infusion1. Liposuction of the anterior abdominal subcutaneous fat layer of participant 2. Characterization and Identification of mesenchymal stem cells 3. Differentiation of mesenchymal stem cells into insulin producing stem cells 4. In vitro detection of Insulin and c-peptide in differentiated MSC (Confirmatory tests for the insulin producing cells) 5. In vitro Insulin and c-peptide release detection in differentiated MSC in response to increasing glucose concentrations Differentiated MSCs injection in human subjects 6. Followup | Biological | group 1a IPSC transplant in portal circulation, group 1b IPSC in peripheral systemic circulation |
Primary outcome
Insulin producing mesenchymal stem cells efficacy in insulin production in vitro
Time frame: 1 year
Assessment of the percentage of mature insulin and c peptide production in insulin producing stem cells.
Insulin producing mesenchymal stem cells efficacy in insulin production in vitro
Time frame: 1 year
Assestment of percentage of mature insulin production and c peptide in insulin producing stem cells in response to different concentrations of glucose.
Insulin producing mesenchymal stem cells efficacy in insulin production in vivo
Time frame: 1 year
Participants glycemic control will be assesed before and after insulin producing stem cells injection.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Background: PubMed 39710778Abou Zaki R, El-Osta A. Advancing type 1 diabetes therapy: autologous islet transplant breakthrough. Signal Transduct Target Ther. 2024 Dec 23;9(1):366. doi: 10.1038/s41392-024-02090-x. No abstract available.
- Background: PubMed 30777564Ulyanova O, Askarov M, Kozina L, Karibekov T, Shaimardanova G, Zhakupova A, Danilova D, Serebrennikova D. Autologous Mesenchymal Stem Cell Transplant in Patients with Type 1 Diabetes Mellitus. Exp Clin Transplant. 2019 Jan;17(Suppl 1):236-238. doi: 10.6002/ect.MESOT2018.P100.
- Background: PubMed 36042996Jayasinghe M, Prathiraja O, Perera PB, Jena R, Silva MS, Weerawarna PSH, Singhal M, Kayani AMA, Karnakoti S, Jain S. The Role of Mesenchymal Stem Cells in the Treatment of Type 1 Diabetes. Cureus. 2022 Jul 27;14(7):e27337. doi: 10.7759/cureus.27337. eCollection 2022 Jul.
- Individual participant dataSharing planned: No
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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.
Rasha S Elmetwally, A. Prof principal investigator
Assistant professor of Pediatrics, Faculty of Medicine, Ain Shams University
Randa M Matter, Prof study director
Professor of pediatrics, Faculty of Medicine, Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Insulin producing stem cells infusion in people with Stem Cells and Type 1 Diabetes, run by Ain Shams University at 1 site in Egypt.
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 1 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 30 Apr 2025. 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 Egypt. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rasha S Elmetwally, MD (20201092143033 ext. 02, dr.rashaeladawy@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin producing mesenchymal stem cells efficacy in insulin production in vitro (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06951074, which also lists 3 linked publications.
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 30 Apr 2025.