Allogeneic Mesenchymal Stem Cell Transplantation in Tibial Closed Diaphyseal Fractures

Royan Institute

Status and phase: Completed; Phase 2

Conditions: Tibial Fracture

Treatments: Biological: Placebo; Biological: Mesenchymal stem cell injection

Study type: Interventional

Funder types: Other

Identifiers

NCT02140528

Royan-Bone-012

Details and patient eligibility

About

This study is a case-control prospective, clinal trial to assess the safety and efficacy of the allogeneic adipose derived mesenchymal stem cell transplantation on the healing of recent tibial fracture in 40 patients.

Full description

In this study all eligible patients divided in 2 group.20 patients received allogeneic adipose derived mesenchymal stem cell in the fractured site (case group) and other patients received the placebo in the fractured site (control group) .

To assess the outcomes, we will evaluate the patients at 2, 6 weeks and 3, 6 months after transplantation by: X-ray, BMD , VAS and biochemical analysis with laboratory tests.

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 to 65 years
• The presence of tibial fracture based on X ray
• tibial fracture is limited to diaphysial

Exclusion criteria

• Addiction
• Pregnancy
• liver or kidney disease or uncontrolled diabetes or heart and lung disease
• immune deficiency

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

40 participants in 2 patient groups, including a placebo group

Mesenchymal stem cell receipients

Experimental group

Description:

Transplantation of allogenic adipose derived mesenchymal stem cells in patients with tibial fracture.

Treatment:

Biological: Mesenchymal stem cell injection

Placebo

Placebo Comparator group

Description:

Placebo injection in the site of fracture in patients with tibia fracture.

Treatment:

Biological: Placebo