DiabetesPhase 1NCT05003908
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for Diabetes
A Phase 1 study testing AlloRx in people with Diabetes, run by The Foundation for Orthopaedics and Regenerative Medicine at 2 sites in 2 countries.
Trial summary
This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Diabetes Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes
- What is being tested?
- AlloRx
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 6 Nov 2021to 4 Apr 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of Diabetes
- Understanding and willingness to sign a written informed consent document
Who cannot join
- Active infection
- Active cancer
- Chronic multisystem organ failure
- Pregnancy
- Clinically significant Abnormalities on pre-treatment laboratory evaluation
- Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
Show all 10Show fewer
- Continued drug abuse
- Pre-menopausal women not using contraception
- Previous organ transplant
- Hypersensitivity to sulfur
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Antigua and Barbuda1 site
Medical Surgical Associates Center
St John's
Argentina1 site
Center for Investigation in Tissue Engineering and Cellular Therapy
Buenos Aires
About this study
Official title: Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Diabetes
This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Diabetes
Read the detailed description
Studies have shown that stem cell treatment is safe and efficacious for the treatment of Diabetes. Patients with Diabetes will receive a single intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.
For patients with more severe disease requiring chemotherapeutic drugs such as methotrexate, an autologous T Cell vaccine will be utilized created from the patient's own T cells obtained by apheresis.
- Conditions
- Diabetes
- Being tested
- AlloRx
- Keywords
- Diabetes, stem cell treatment
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlloRxBiological
cultured allogeneic adult umbilical cord derived mesenchymal stem cells
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Single intravenous infusion of 100 million cells Receives: Biological: AlloRx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety (adverse events)
Clinical monitoring of possible adverse events or complications
Measured: Four year follow-up
Secondary outcomes (3)
Efficacy: the level of A1C
A1C blood test will be completed for each follow up point.
Measured: Four year follow-up
Efficacy: the level of C-Peptide
C-Peptide test will be completed for each follow up point.
Measured: Four year follow-up
Efficacy: Insulin dose reduction
Changes of insulin dosage for each follow up point.
Measured: Four year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start6 Nov 2021
- Primary completion4 Apr 2025
- Study completion4 Apr 2025
Why it stopped: Inadequate treatment response observed in preliminary data did not justify enrolling further study participants
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 DiabetesStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Foundation for Orthopaedics and Regenerative Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chadwick Prodromos, MD, Principal investigator, The Foundation for Orthopaedics and Regenerative Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05003908
- Sponsor's protocol ID
- SC-10-ATG-11-01
- Status last verified
- Oct 2026
- First submitted
- 6 Aug 2021
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Hu J, Yu X, Wang Z, Wang F, Wang L, Gao H, Chen Y, Zhao W, Jia Z, Yan S, Wang Y. Long term effects of the implantation of Wharton's jelly-derived mesenchymal stem cells from the umbilical cord for newly-onset type 1 diabetes mellitus. Endocr J. 2013;60(3):347-57. doi: 10.1507/endocrj.ej12-0343. Epub 2012 Nov 16.
PubMed 23154532Jiang R, Han Z, Zhuo G, Qu X, Li X, Wang X, Shao Y, Yang S, Han ZC. Transplantation of placenta-derived mesenchymal stem cells in type 2 diabetes: a pilot study. Front Med. 2011 Mar;5(1):94-100. doi: 10.1007/s11684-011-0116-z. Epub 2011 Mar 17.
PubMed 21681681Cai J, Wu Z, Xu X, Liao L, Chen J, Huang L, Wu W, Luo F, Wu C, Pugliese A, Pileggi A, Ricordi C, Tan J. Umbilical Cord Mesenchymal Stromal Cell With Autologous Bone Marrow Cell Transplantation in Established Type 1 Diabetes: A Pilot Randomized Controlled Open-Label Clinical Study to Assess Safety and Impact on Insulin Secretion. Diabetes Care. 2016 Jan;39(1):149-57. doi: 10.2337/dc15-0171. Epub 2015 Dec 1.
PubMed 26628416
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Diabetes
- ClinicalTrials.gov ID
- NCT05003908
- Acronym / sponsor ID
- SC-10-ATG-11-01
- Conditions
- Diabetes
- Keywords
- Diabetes, stem cell treatment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inadequate treatment response observed in preliminary data did not justify enrolling further study participants
- Enrolment
- 2 participants (actual)
- Lead sponsor
- The Foundation for Orthopaedics and Regenerative MedicineUniversity, hospital or other
- Study start
- 6 Nov 2021 (actual)
- Primary completion
- 4 Apr 2025 (actual)
- Study completion
- 4 Apr 2025 (actual)
- First posted
- 13 Aug 2021 (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.
This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Diabetes
Detailed description
Studies have shown that stem cell treatment is safe and efficacious for the treatment of Diabetes. Patients with Diabetes will receive a single intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.
For patients with more severe disease requiring chemotherapeutic drugs such as methotrexate, an autologous T Cell vaccine will be utilized created from the patient's own T cells obtained by apheresis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Biological: AlloRxSingle intravenous infusion of 100 million cells |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of Diabetes
- Understanding and willingness to sign a written informed consent document
Key exclusion criteria (10 listed)
- Active infection
- Active cancer
- Chronic multisystem organ failure
- Pregnancy
- Clinically significant Abnormalities on pre-treatment laboratory evaluation
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 |
|---|---|---|
| AlloRxcultured allogeneic adult umbilical cord derived mesenchymal stem cells | Biological | Treatment Group |
Primary outcome
Safety (adverse events)
Time frame: Four year follow-up
Clinical monitoring of possible adverse events or complications
3 secondary outcomes
Efficacy: the level of A1C
Time frame: Four year follow-up
Efficacy: the level of C-Peptide
Time frame: Four year follow-up
Efficacy: Insulin dose reduction
Time frame: Four year follow-up
Results and safety
The study was stopped early (reason given: Inadequate treatment response observed in preliminary data did not justify enrolling further study participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Background: PubMed 23154532Hu J, Yu X, Wang Z, Wang F, Wang L, Gao H, Chen Y, Zhao W, Jia Z, Yan S, Wang Y. Long term effects of the implantation of Wharton's jelly-derived mesenchymal stem cells from the umbilical cord for newly-onset type 1 diabetes mellitus. Endocr J. 2013;60(3):347-57. doi: 10.1507/endocrj.ej12-0343. Epub 2012 Nov 16.
- Background: PubMed 21681681Jiang R, Han Z, Zhuo G, Qu X, Li X, Wang X, Shao Y, Yang S, Han ZC. Transplantation of placenta-derived mesenchymal stem cells in type 2 diabetes: a pilot study. Front Med. 2011 Mar;5(1):94-100. doi: 10.1007/s11684-011-0116-z. Epub 2011 Mar 17.
- Background: PubMed 26628416Cai J, Wu Z, Xu X, Liao L, Chen J, Huang L, Wu W, Luo F, Wu C, Pugliese A, Pileggi A, Ricordi C, Tan J. Umbilical Cord Mesenchymal Stromal Cell With Autologous Bone Marrow Cell Transplantation in Established Type 1 Diabetes: A Pilot Randomized Controlled Open-Label Clinical Study to Assess Safety and Impact on Insulin Secretion. Diabetes Care. 2016 Jan;39(1):149-57. doi: 10.2337/dc15-0171. Epub 2015 Dec 1.
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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.
Chadwick Prodromos, MD principal investigator
The Foundation for Orthopaedics and Regenerative Medicine
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AlloRx in people with Diabetes, run by The Foundation for Orthopaedics and Regenerative Medicine at 2 sites in 2 countries.
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 2 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: stopped early, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Antigua and Barbuda, Argentina. 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?
The study was stopped early (reason given: Inadequate treatment response observed in preliminary data did not justify enrolling further study participants). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (adverse events) (time frame: Four year follow-up). 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 NCT05003908, 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 20 Oct 2026.