Autologous BM-MSC Transplantation in Combination With Platelet Lysate (PL) for Nonunion Treatment

Bone Fracture Clinical Trial

Official title:

Use of Autologous Bone Marrow Derived Mesenchymal Stromal Cells in Combination With Platelet Lysate Product for Human Long Bone Nonunion Treatment, A Phase 2-3 Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02448849
• Other study ID #: Royan-Bone-013
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: May 5, 2015
• Last updated: October 29, 2015
• Start date: June 2015
• Est. completion date: August 2017

Study information

• Verified date: September 2015
• Source: Royan Institute
• Contact: Nasser Aghdami, MD, PhD
• Phone: (+98)23562000
• Email: nasser.aghdami[@]royaninstitute.org
• Is FDA regulated: No
• Health authority: Iran: Ethics CommitteeIran: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Nonunion of long bones would occur in almost 10% of fractures and because of its long term and complicated treatment, is known as a therapeutic challenge for both of the surgeons and patients.

Cell therapy is useful in treatment of nonunion and mesenchymal stromal/stem cells are the best candidates for this kind of treatment.

Percutaneous implantation of autologous bone marrow derived mesenchymal stromal/stem cell in combination with PL will be done in 30 patients with tibia nonunion. The other 30 patients as the control group will receive placebo. The patients will be followed at 2weeks, 3months, 6m and 12 months after implantation.

The Spss(v16) software will be used for data analysis.

Description:

Long bone nonunion is known as a therapeutic challenge for both the orthopedic surgeons and the society. Current treatment of this disorder is autologous bone graft. This treatment has potential minor and major complications and is considered as a risky treatment. So researches are focused on new treatment approaches for this disease.

Cell therapy is one of these new approaches especially based on mesenchymal stromal cells.

The investigators will evaluate safety and efficacy of percutaneous implantation of autologous BM-MSC (bone marrow -derived mesenchymal stromal cell) in combination with PL (platelet lysate product) in 30 tibia nonunion patients. The other 30 patients will receive placebo. These patients will be followed up and data will be analyzed with spss(v16).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

inclusion criteria:

• Non-united fracture of tibial midshaft at X-ray.

• Non-united gap less than 1cm.

• Fracture has fixed by closed intramedullary rod.

• Hypotrophic type.

• At least 6 months after initial surgery.

• Patient informed consent.

Exclusion criteria:

• Infected nonunion

• Multiple major fracture

• Non treated major fracture

• malignancy

• Pregnancy or lactating

• Uncontrolled chronic diseases, such as: diabetes mellitus, hypertension, renal diseases, liver diseases, thyroid diseases, heart diseases, blood diseases, etc.

• Steroid usage.

• Positive test for HIV and/or HBS and/or HBC and/or HTLV (1,2)

• Fracture site more than 1 cm.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bone Fracture
• Fractures, Bone

Intervention

Biological:
• Percutaneous injection
percutanous implantation of bone marrow derived mesenchymal stromal cells in patients with nonunion fracture.

Other:
• Percutaneous injection
Percutaneous implantation of placebo in patients with nonunion fracture.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Royan Institute	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Royan Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical union	- Clinical union is defined as an asymptomatic patient who was able to fully bear weight on the injured leg	3months	Yes
Primary	Radiological healing	- radiographic fracture healing is defined by bone continuity (bony bridging) present in three out of four cortices in two projections (anterior-posterior & lateral x-rays), assessed by a blinded senior orthopedic surgeon.; CT scan, for confirm the results - radiolographic fracture healing is defined by bone continuity (bony bridging) present in three out of four cortices in two projections (anterior-posterior & lateral x-rays), assessed by a blinded senior orthopedic surgeon.; CT scan, for confirm the results; - radiolographic fracture healing is defined by bone continuity (bony bridging) present in three out of four cortices in two projections (anterior-posterior & lateral x-rays), assessed by a blinded senior orthopedic surgeon.; CT scan, for confirm the results	1week	Yes
Secondary	Pain	The pain relief as measured by Visual Analogue Scale (VAS) 3 months after cell injection	3months	Yes
Secondary	Quality of life	Evaluation the patients' quality of life with Visual Analogue Score (VAS) 3months after cell transplantation.	3months	Yes
Secondary	Walking distance	Walking distance changes as measured by walking on treadmill 3 months after cell injection.	3months	Yes

External Links

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