Autologous BM-MSC Transplantation in Combination With Platelet Lysate (PL) for Nonunion Treatment
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
1 other identifier
interventional
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 5, 2015
CompletedFirst Posted
Study publicly available on registry
May 20, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedOctober 30, 2015
September 1, 2015
1.8 years
May 5, 2015
October 29, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
clinical union
\- Clinical union is defined as an asymptomatic patient who was able to fully bear weight on the injured leg
3months
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
Secondary Outcomes (3)
Pain
3months
Quality of life
3months
Walking distance
3months
Study Arms (2)
MSC recipients
EXPERIMENTALThe patients with nonunion fracture who underwent percutaneous implantation of bone marrow derived mesenchymal stem cells in combination with platelet lysate product.
Placebo
PLACEBO COMPARATORThe patients with nonunion fracture who underwent percutaneous injection of placebo.
Interventions
percutanous implantation of bone marrow derived mesenchymal stromal cells in patients with nonunion fracture.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Royan Institutelead
Study Sites (1)
Royan Institute
Tehran, Iran
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hamid Gourabi, PhD
Head of Royan Institute
- STUDY DIRECTOR
Nasser Aghdami, MD,PhD
Head of Regenerative medicine department and cell therapy center of Royan Institute
- STUDY DIRECTOR
Mohammad Razi, MD
Department of orthopedic surgery, Tehran university of medical science, Tehran, Iran
- PRINCIPAL INVESTIGATOR
Mohsen Emadedin, MD
Cell therapy center of Royan Institute
- PRINCIPAL INVESTIGATOR
Narges Labibzadeh, MD
Department of Regenerative Medicine and cell therapy center, Royan Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2015
First Posted
May 20, 2015
Study Start
June 1, 2015
Primary Completion
April 1, 2017
Study Completion
August 1, 2017
Last Updated
October 30, 2015
Record last verified: 2015-09