Investigation of Dose Escalation and Dose Expansion Study on the Safety and Efficacy of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells Combined With Allogeneic Islet Transplantation for the Treatment of Diabetes

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The aim is to Investigate the safety and efficacy of Portal vein infusion Allogeneic Human umbilical cord mesenchymal stem cells combined with Allogeneic islet transplantation for the treatment of diabetes

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: t
View:

• Meets the 1999 World Health Organization diagnostic criteria for diabetes.

• Aged 18-70, no gender restriction.

• Islet function failure: fasting C-peptide \< 0.1 nmol/L, 2-hour postprandial C-peptide \< 0.2 nmol/L, and HbA1c ≥ 7%.

• Meets the indications for islet transplantation alone:

• i. Type 1 diabetes patients who experience unstable blood glucose despite strict insulin therapy, including frequent hypoglycemia or at least one severe hypoglycemic event in the past 12 months, or those with serious complications in other organs such as the kidneys; ii. Type 2 diabetes progressing to islet failure with poor blood glucose control as described above; iii. Patients with chronic pancreatitis or non-malignant pancreatic tumors who have undergone total or near-total pancreatectomy may receive autologous islet transplantation concurrently or allogeneic islet transplantation later.

• The patient and their family or legal guardian voluntarily consent to stem cell transplantation therapy and sign the informed consent form.

Locations
Other Locations
China
Shanghai Changzheng Hospital
RECRUITING
Shanghai
Contact Information
Primary
Hao Yin
yinhaoshanghai@163.com
13901677738
Time Frame
Start Date: 2024-12-30
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 16
Treatments
Experimental: Experimental
allogeneic islet combined with hUCMSCs
Active_comparator: Comparator
allogeneic islet
Related Therapeutic Areas
Sponsors
Leads: Shanghai Changzheng Hospital

This content was sourced from clinicaltrials.gov