evaluation of efficacy and side effects of implantation of bone marrow-derived mesenchymal stromal cells in combination with platelet lysate product in reconstruction of human nonunion of tibia fractures/a phase2 & 3 clinical trial
Objectives: evaluation of effect of implantation of autologous mesenchymal stromal cells in combination with platelet lysate product, in clinical and radiological signs and symptoms relief in patients with long bone nonunion.
Design: study groups and phase: two groups: case and control, phase 2& 3. Sample size: 60 patients, triple blind, randomized, single center. Setting and conduct: after autologous bone marrow aspiration, mesenchymal stromal cells will be separated and then they will be implanted into the callus site of case group in combination with platelet lysate product. For control group normal saline will be injected into the callus site.
Participants: 1-patients with nonunion of tibial midshaft. 2- Fracture must be located in the middle third of the tibia. 3- Nonunion gap must be less than 1 cm. in the radiology. 4- Fracture fixed by closed intra medullary rod. 5- Patient informed the consent. 6- Atrophic type nonunion 7- 6 months last from the first operation. 8- Second procedure for nonunion has not done.
Exclusion criteria: 1- infected nonunion 2- multiple major fractures. 3- Multiple major untreated fractures. Intervention: autologous bone marrow derived stromal cells implantation in patients with atrophic nonunion and normal saline as the placebo for control group. Main out comes: primary outcomes: fracture healing in patients with nonunion. Pain relief, evaluation of walking distance. Secondary outcomes: evaluation of tumor formation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201507291031N7
Registration date:2015-09-09, 1394/06/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-09-09, 1394/06/18
Registrant information
Name
Nasser Aghdami
Name of organization / entity
Royan Institute
Country
Iran (Islamic Republic of)
Phone
+98 21 2356 2000
Email address
nasser.aghdami@royaninstitute.org
Recruitment status
Recruitment complete
Funding source
Department of Regenerative Biomedicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR
Expected recruitment start date
2009-02-18, 1387/11/30
Expected recruitment end date
2011-04-20, 1390/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
evaluation of efficacy and side effects of implantation of bone marrow-derived mesenchymal stromal cells in combination with platelet lysate product in reconstruction of human nonunion of tibia fractures/a phase2 & 3 clinical trial
Public title
Reconstruction of human nonunion of tibia fractures
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:1-patients with 18-65 years old; 2- both male & female patients; 3- patients with nonunion of tibial midshaft; 4- Fracture must be located in the middle third of the tibia; 5- Nonunion gap must be less than 1 cm. in the radiology; 6- Fracture fixed by closed intra medullary rod; 7- Patient informed the consent; 8- Atrophic type nonunion; 9- 6 months last from the first operation; 10- Second procedure for nonunion has not done.
Exclusion criteria:1- infected nonunion; 2- Multiple major fractures; 3- Major untreated fracture; 4- History of cancer; 5- Allergy to protein or other cell culture medium gradients; 6- Uncontrolled chronic diseases; 7- Need to steroid usage in the period of treatment; 8- Positive for HIV or other viral diseases; 9- Pregnant or lactating women; 10- Include in other trail
Control group: implantation of normal saline as the placebo into the nonunion site.
Category
Treatment - Drugs
2
Description
Intervention group:
Stromal cell therapy: by using autologous bone marrow derived stromal cells.
After bone marrow aspiration, mesenchymal stromal cells will be separated and then they will be implanted to the nonunion site under the guide of fluoroscopy.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Akhtar Hospital
Full name of responsible person
Mohammadreza Abbasian
Street address
Next to Ayatollah Taleghani Hospital, Shahid A'rabi Avenue, Yaman Avenue, Shahid Chamran Highway, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Department of Regenerative Biomedicine, Cell Science Research Center, Royan Institute for Stem Cell