Study of the safety and efficacy of autologous stem cell 3D bioprinted blood vessels for vascular replacement in patients with peripheral limb arterial disease

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100049901

Enrollment

Unknown

Registered

2021-08-10

Start date

2021-08-04

Completion date

Unknown

Last updated

2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral limb arterial disease

Interventions

group 1:Autologous stem cell 3D bioprinted blood vessel implantation

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Male or female aged 18 to 65 years; 2. Clearly diagnosed as peripheral arterial disease (occlusive disease, traumatic disease, spontaneous injury disease), severe limb ischemia or potential rupture and bleeding, non-emergency surgical treatment; 3. Patients who are not suitable or unwilling to receive endovascular treatment; 4. The patient's diseased peripheral arteries have appropriate inflow and outflow tracts: (1) Appropriate inflow tract: Preoperative color Doppler and CTA showed normal inflow tract arterial blood flow, or good inflow tract arterial pulse during intraoperative exploration, or good inflow tract arterial pulse after intraoperative catheter thrombectomy; (2) Appropriate outflow tract: preoperative color Doppler and CTA show outflow tract arterial signal images, or good outflow tract arterial regurgitation during intraoperative exploration, or good outflow tract arterial regurgitation after intraoperative catheter thrombectomy; 5. The investigator judges that it is suitable for surgical vascular replacement surgery; 6. The patient voluntarily signed the ICF, and was able to follow the protocol to complete the follow-up and examination as planned; 7. The length of the total vessel segment of the lesion is <= 10 cm.

Exclusion criteria

Exclusion criteria: 1. Women who are breastfeeding or pregnant, or women or men who are planning to have children recently; 2. Life expectancy = 2.5 mg/dL within 30 days before surgery, or receiving dialysis treatment).

Design outcomes

Primary

Measure	Time frame
Device success rate;Successful operation rate;Graft patency rate;Primary safety endpoint;	—

Secondary

Measure	Time frame
In the 6th month after the operation, the primary patency rate of the blood vessel of the product;Secondary safety indicators;	—

Countries

China

Contacts

Public ContactZhao Jichun

West China Hospital of Sichuan University

zhaojc3@163.com+86 189806061368

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026