Non Union FractureEarly Phase 1AMSCNCT02307435
Allogenic Mesenchymal Stem Cell for Bone Defect or Non Union Fracture
A Early Phase 1 study testing MSC in people with Non Union Fracture and Metaphyseal Fibrous Defect, run by Universitas Indonesia at 2 sites in Indonesia.
Trial summary
Mesenchymal stem cell (MSC) is one kind of stem cell which is gained form adult tissue. Although MSC derived from autogenic bone marrow are proven to help regeneration in non union fracture and long bone defect, the aspiration process through iliac crest is invasive and painful. Read more about this study
- Who is it for?
- Ages 19 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Non Union Fracture, Metaphyseal Fibrous Defect
- What is being tested?
- MSC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesIndonesia
- Study dates
- Aug 2014to Dec 2017
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Bone marrow donor : Male/female aged 19-30 year without any comorbiditites (Diabetes mellitus, cardiovascular and any other autoimmune disease),HIV test Hepatitis B test and Hepatitis C test are negaitve, no fungal and bacterial contamination in the bone marrow. Subjects are willing to be aspiratied in the iliac crest in order to get the bone marrow.
- Adipose donor : Adipose tissue are gained from liposuction or open reduction internal fixation procedure. Samples of adipose are free from HIV, Hepatitis B, Hepatitis C and free from fungal and bacterial contamination.
- Umbilical cord donor : Umbilical cord are form elective seccio caecaria from a fullterm mother without any complications and free from HIV, hepatitis B, hepatitis C and no fungal and bacterial contamination.
Who cannot join
- -Patients are ruled out from this study if he/she stated to do so in the time this research are held or she/he undergoes any other threatment that are not related to this study. Patient who does not show any clinical improvement in three consecutive months is categorized as failed to threat. All drop out and failed to threat patient could get other threatment.
- inclusion criteria for recipient : -male/female aged 6-55 year old with bone critical defect
- -Patients with pathological fracture caused by malignancy, immunocompromised ( HIV AIDS, Diabetes mellitus, active Hepatitis), in a immunosuppresant therapy ( chemotherapy or steroids).
Trial locations and contacts
2 sites in 1 country.
Indonesia2 sites, 2 recruiting
- Recruiting
University of Indonesia
Jakarta Pusat, Jakarta Special Capital Region, 10430
TRI KURNIAWATI, BSc, +6221 44539917, SELPUNCARSCM@YAHOO.CO.ID
PRIMA R OKTARI, MD, +6281238107568, PRIMARIZKYOKTARI@GMAIL.COM
- Recruiting
Faculty of Medicine, University of Indonesia
Propinsi DKI Jakarta, Jakarta Special Capital Region, 16424
ISMAIL H DILOGO, MD, +628129499428, ISMAILORTHO@GMAIL.COM
PRIMA R OKTARI, MD, +6281238107568, PRIMARIZKYOKTARI@GMAIL.COM
About this study
Official title: Potency of Allogenic Bone Marrow, Umbilical Cord, Adipose Mesenchymal Stem Cell for Non Union Fracture and Long Bone Defect, Directly and Cryopreserved
Mesenchymal stem cell (MSC) is one kind of stem cell which is gained form adult tissue. Although MSC derived from autogenic bone marrow are proven to help regeneration in non union fracture and long bone defect, the aspiration process through iliac crest is invasive and painful.
Therefore, alternative source of MSC which is less invasive is needed. Adipose and umbilical cord is a "waste product" that proven to contain enormous MSC. Furthermore adipose and umbilical cord as an allogenic source is more abundant in number compares to autogenic bone marrow. This enormous source need and adequate preservation technique before applied to the patient. According to that, researchers want to explore the potency of MSC from bone marrow, umbilical cord and adipose as the source of allogenic MSC and the effect of cryopreservation technique to the viability and quality of MSC. We will also compare the effectivity of MSC implantation from bone marrow, umbilical cord and adipose applied to non union fracture and long bone defect.
Samples from bone marrow, umbilical cord and adipose are cultured and the viability of the cells are observed. Some of the cells are implanted directly to the patient with non union fractures and long bone defect while some are cryopreserved in liquid nitrogen -190 degree Celsius in three months. All samples are thawed and the viability of the cells are observed. Patient who are implanted by MSC allogenic will undergo clinical and radiological examination in the third, sixth and twenty second month after implantation.
Read the detailed description
Research Methods Study Design This study is an experimental one arm study post test only. Estimated Study Time Research estimated time would be 24 months, from May 2014 to May 2016. Sample Gaining Procedure This research is a pilot study. Samples are obtained consecutively from all source population that meet the criteria. The number of samples from each mesenchymal stem cell ( adipose, bone marrow and umbilical cord) source are three. Each samples derived from three different donors that met the inclusion criteria. For the implanation, the subjects are five from each intervention. Yet regarding the limited funding source and time, we will recruit one subject for each kind of MSC.
Subject Criteria Inclusion criteria for MSC donor
Bone marrow donor :
Male/female aged 19-30 year without any comorbiditites (Diabetes mellitus, cardiovascular and any other autoimmune disease), HIV test Hepatitis B test and Hepatitis C test are negaitve, no fungal and bacterial contamination in the bone marrow. Subjects are willing to be aspiratied in the iliac crest in order to get the bone marrow.
Adipose donor :
Adipose tissue are gained from liposuction or open reduction internal fixation procedure. Samples of adipose are free from HIV, Hepatitis B, Hepatitis C and free from fungal and bacterial contamination.
Umbilical cord donor :
Umbilical cord are form elective seccio caecaria from a fullterm mother without any complications and free from HIV, hepatitis B, hepatitis C and no fungal and bacterial contamination.
Recipient inclusion criteria Critical bone defect patients aged 6-55 who are willing to undergo surgical intervention.
Recipient exclusion criteria Patients with pathological fracture caused by malignancy, immunocompromised ( HIV AIDS, Diabetes mellitus, active Hepatitis), in a immunosuppresant therapy ( chemotherapy or steroids).
Drop out criteria Patients are ruled out from this study if he/she stated to do so in the time this research are held or she/he undergoes any other threatment that are not related to this study. Patient who does not show any clinical improvement in three consecutive months is categorized as failed to threat. All drop out and failed to threat patient could get other threatment.
Informed Consent All subjects must fill and sign in the informed consent letters.
Research Protocol Mesenchymal stem cell taking method Bone Marrow taking Patient is lying down in supine position, anesthetized locally. Aseptic and antiseptic are done in the illiac crest location. Aspiration needle is inserted 450 to horizon in illiac crest. Hub is released and a 10 cc syringe that contain heparin is connected to te needle. We aspirated about 50 cc bone marrow from each subject.
Umbilical cord taking Right after the delivering the baby, the umbilical cord are cut and kept in a sterile bowl containing 0.9% NaCl in 40 until the sample is proceed.
Adipose taking Adipose tissue are derived from liposuction or open reduction internal fixation procedure. It is kept in a sterile bowl containing NaCL 0.9% in 40 C. Processing of the sample is done within 8 hours after sample are taken.
Cryopreservation and re activation. All the samples are taken to culture laboratory in integrated service of stem cell medical technology Cipto mangunkusumo hospita.this laboratory is GMP (good manufacturing Product) certified. The samples ate cultured in appropriated medium until it reach confluence and harvested. The cells then undergo caracterisation test by flow cyto meter and viability and numbers are counted. Some of the cells then cryopreserved while some are directly implanted into patient. The cells are cryopreserved for three months and then reactivated. Viability and numbers then are measured. The cells then are implanted to non union patient.
Specimen sterility Sterility tests are done three times to ensure there is no fungal and bacterial contamination.
HA-CaSO4 and MSC For every centimeter of defect, 10 millions cells and 50 pellet HA-CaSO4 are needed. The diluted MSC then mix with the HA-CaSO4 and incubated 5 minutes before implanted.
Intervention Surgical intervention is needed to assemble the fixation device in the long bone. During the surgery, pellet HA-CaSO4 are inserted into the defect. After soft tissue are closed the rest of the serum is injected into the defect area.
Observation and follow up Clinical and radiological follow up is done every 4 weeks. Observation is done for 12 months or untill the bone unites. Every subject will be followed up in the third, sixth, twelfth and twenty forth or until the fixation device is taken off.
Recipient criteria for non union fracture
- Conditions
- Non Union Fracture, Metaphyseal Fibrous Defect
- Being tested
- MSC
- Keywords
- non union fracture, bone defect, mesenchymal stem cell, cryopreservation
- Medical subject headings
- Fractures, Ununited
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSCBiological
subjects are implanted with allogenic mesenchymal stem cells from umbilical cord/ bone marrow/ adipose
| Study group | Role | What they receive |
|---|---|---|
| implantation group | Experimental | implantation group will receive MSC and HA-CaSo4 Receives: Biological: MSC |
What is being measured
The primary outcome is the main question the study is designed to answer.
cell viability
percentage of cells that live divided by total cell
Measured: 3 months
Secondary outcomes (2)
lower extremity functional score
lower extremities functional score sheet
Measured: 3 months
disabilities of arm shoulder and hand
disabilities of arm shoulder and hand score
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for Non Union FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ismail Hadisoebroto Dilogo, Universitas Indonesia
- Investigators
- ISMAIL H DILOGO, MD, Principal investigator, integrated unit of stem cell and medical technology CIPTO MANGUNKUSUMO GENERAL HOSPITAL, FACULTY OF MEDICINE UNIVERSITI OF INDONESIA, INDONESIAismail h dilogo, MD, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02307435
- Sponsor's protocol ID
- ISMMSC001
- Acronym
- AMSC
- Status last verified
- Dec 2014
- First submitted
- 7 Oct 2014
- Last updated
- 4 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Kon E, Muraglia A, Corsi A, Bianco P, Marcacci M, Martin I, Boyde A, Ruspantini I, Chistolini P, Rocca M, Giardino R, Cancedda R, Quarto R. Autologous bone marrow stromal cells loaded onto porous hydroxyapatite ceramic accelerate bone repair in critical-size defects of sheep long bones. J Biomed Mater Res. 2000 Mar 5;49(3):328-37. doi: 10.1002/(sici)1097-4636(20000305)49:33.0.co;2-q.
PubMed 10602065Hee HT, Ismail HD, Lim CT, Goh JC, Wong HK. Effects of implantation of bone marrow mesenchymal stem cells, disc distraction and combined therapy on reversing degeneration of the intervertebral disc. J Bone Joint Surg Br. 2010 May;92(5):726-36. doi: 10.1302/0301-620X.92B5.23015.
PubMed 20436013Ye Z, Wang Y, Xie HY, Zheng SS. Immunosuppressive effects of rat mesenchymal stem cells: involvement of CD4+CD25+ regulatory T cells. Hepatobiliary Pancreat Dis Int. 2008 Dec;7(6):608-14.
PubMed 19073406Bocelli-Tyndall C, Bracci L, Spagnoli G, Braccini A, Bouchenaki M, Ceredig R, Pistoia V, Martin I, Tyndall A. Bone marrow mesenchymal stromal cells (BM-MSCs) from healthy donors and auto-immune disease patients reduce the proliferation of autologous- and allogeneic-stimulated lymphocytes in vitro. Rheumatology (Oxford). 2007 Mar;46(3):403-8. doi: 10.1093/rheumatology/kel267. Epub 2006 Aug 18.
PubMed 16920750Yanez R, Lamana ML, Garcia-Castro J, Colmenero I, Ramirez M, Bueren JA. Adipose tissue-derived mesenchymal stem cells have in vivo immunosuppressive properties applicable for the control of the graft-versus-host disease. Stem Cells. 2006 Nov;24(11):2582-91. doi: 10.1634/stemcells.2006-0228. Epub 2006 Jul 27.
PubMed 16873762Tipnis S, Viswanathan C, Majumdar AS. Immunosuppressive properties of human umbilical cord-derived mesenchymal stem cells: role of B7-H1 and IDO. Immunol Cell Biol. 2010 Nov-Dec;88(8):795-806. doi: 10.1038/icb.2010.47. Epub 2010 Apr 13.
PubMed 20386557Hou ZL, Liu Y, Mao XH, Wei CY, Meng MY, Liu YH, Zhuyun Yang Z, Zhu H, Short M, Bernard C, Xiao ZC. Transplantation of umbilical cord and bone marrow-derived mesenchymal stem cells in a patient with relapsing-remitting multiple sclerosis. Cell Adh Migr. 2013 Sep-Oct;7(5):404-7. doi: 10.4161/cam.26941. Epub 2013 Oct 30.
PubMed 24192520Brinker MR, O'Connor DP. The incidence of fractures and dislocations referred for orthopaedic services in a capitated population. J Bone Joint Surg Am. 2004 Feb;86(2):290-7.
PubMed 14960673Liebergall M, Schroeder J, Mosheiff R, Gazit Z, Yoram Z, Rasooly L, Daskal A, Khoury A, Weil Y, Beyth S. Stem cell-based therapy for prevention of delayed fracture union: a randomized and prospective preliminary study. Mol Ther. 2013 Aug;21(8):1631-8. doi: 10.1038/mt.2013.109. Epub 2013 Jun 4.
PubMed 23732992Sen MK, Miclau T. Autologous iliac crest bone graft: should it still be the gold standard for treating nonunions? Injury. 2007 Mar;38 Suppl 1:S75-80. doi: 10.1016/j.injury.2007.02.012.
PubMed 17383488Goulet JA, Senunas LE, DeSilva GL, Greenfield ML. Autogenous iliac crest bone graft. Complications and functional assessment. Clin Orthop Relat Res. 1997 Jun;(339):76-81. doi: 10.1097/00003086-199706000-00011.
PubMed 9186204Mauney JR, Volloch V, Kaplan DL. Role of adult mesenchymal stem cells in bone tissue engineering applications: current status and future prospects. Tissue Eng. 2005 May-Jun;11(5-6):787-802. doi: 10.1089/ten.2005.11.787.
PubMed 15998219Cavallo C, Cuomo C, Fantini S, Ricci F, Tazzari PL, Lucarelli E, Donati D, Facchini A, Lisignoli G, Fornasari PM, Grigolo B, Moroni L. Comparison of alternative mesenchymal stem cell sources for cell banking and musculoskeletal advanced therapies. J Cell Biochem. 2011 May;112(5):1418-30. doi: 10.1002/jcb.23058.
PubMed 21321995Jurgens WJ, Oedayrajsingh-Varma MJ, Helder MN, Zandiehdoulabi B, Schouten TE, Kuik DJ, Ritt MJ, van Milligen FJ. Effect of tissue-harvesting site on yield of stem cells derived from adipose tissue: implications for cell-based therapies. Cell Tissue Res. 2008 Jun;332(3):415-26. doi: 10.1007/s00441-007-0555-7. Epub 2008 Apr 1.
PubMed 18379826Lu Z, Wang G, Dunstan CR, Chen Y, Lu WY, Davies B, Zreiqat H. Activation and promotion of adipose stem cells by tumour necrosis factor-alpha preconditioning for bone regeneration. J Cell Physiol. 2013 Aug;228(8):1737-44. doi: 10.1002/jcp.24330.
PubMed 23359411
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potency of Allogenic Bone Marrow, Umbilical Cord, Adipose Mesenchymal Stem Cell for Non Union Fracture and Long Bone Defect, Directly and Cryopreserved
- ClinicalTrials.gov ID
- NCT02307435
- Acronym / sponsor ID
- AMSC / ISMMSC001
- Conditions
- Non Union Fracture, Metaphyseal Fibrous Defect
- Keywords
- non union fracture, bone defect, mesenchymal stem cell, cryopreservation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 4 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Mesenchymal stem cell (MSC) is one kind of stem cell which is gained form adult tissue. Although MSC derived from autogenic bone marrow are proven to help regeneration in non union fracture and long bone defect, the aspiration process through iliac crest is invasive and painful.
Therefore, alternative source of MSC which is less invasive is needed. Adipose and umbilical cord is a "waste product" that proven to contain enormous MSC. Furthermore adipose and umbilical cord as an allogenic source is more abundant in number compares to autogenic bone marrow. This enormous source need and adequate preservation technique before applied to the patient. According to that, researchers want to explore the potency of MSC from bone marrow, umbilical cord and adipose as the source of allogenic MSC and the effect of cryopreservation technique to the viability and quality of MSC. We will also compare the effectivity of MSC implantation from bone marrow, umbilical cord and adipose applied to non union fracture and long bone defect.
Samples from bone marrow, umbilical cord and adipose are cultured and the viability of the cells are observed. Some of the cells are implanted directly to the patient with non union fractures and long bone defect while some are cryopreserved in liquid nitrogen -190 degree Celsius in three months. All samples are thawed and the viability of the cells are observed. Patient who are implanted by MSC allogenic will undergo clinical and radiological examination in the third, sixth and twenty second month after implantation.
Detailed description
Research Methods Study Design This study is an experimental one arm study post test only. Estimated Study Time Research estimated time would be 24 months, from May 2014 to May 2016. Sample Gaining Procedure This research is a pilot study. Samples are obtained consecutively from all source population that meet the criteria. The number of samples from each mesenchymal stem cell ( adipose, bone marrow and umbilical cord) source are three. Each samples derived from three different donors that met the inclusion criteria. For the implanation, the subjects are five from each intervention. Yet regarding the limited funding source and time, we will recruit one subject for each kind of MSC.
Subject Criteria Inclusion criteria for MSC donor
Bone marrow donor :
Male/female aged 19-30 year without any comorbiditites (Diabetes mellitus, cardiovascular and any other autoimmune disease), HIV test Hepatitis B test and Hepatitis C test are negaitve, no fungal and bacterial contamination in the bone marrow. Subjects are willing to be aspiratied in the iliac crest in order to get the bone marrow.
Adipose donor :
Adipose tissue are gained from liposuction or open reduction internal fixation procedure. Samples of adipose are free from HIV, Hepatitis B, Hepatitis C and free from fungal and bacterial contamination.
Umbilical cord donor :
Umbilical cord are form elective seccio caecaria from a fullterm mother without any complications and free from HIV, hepatitis B, hepatitis C and no fungal and bacterial contamination.
Recipient inclusion criteria Critical bone defect patients aged 6-55 who are willing to undergo surgical intervention.
Recipient exclusion criteria Patients with pathological fracture caused by malignancy, immunocompromised ( HIV AIDS, Diabetes mellitus, active Hepatitis), in a immunosuppresant therapy ( chemotherapy or steroids).
Drop out criteria Patients are ruled out from this study if he/she stated to do so in the time this research are held or she/he undergoes any other threatment that are not related to this study. Patient who does not show any clinical improvement in three consecutive months is categorized as failed to threat. All drop out and failed to threat patient could get other threatment.
Informed Consent All subjects must fill and sign in the informed consent letters.
Research Protocol Mesenchymal stem cell taking method Bone Marrow taking Patient is lying down in supine position, anesthetized locally. Aseptic and antiseptic are done in the illiac crest location. Aspiration needle is inserted 450 to horizon in illiac crest. Hub is released and a 10 cc syringe that contain heparin is connected to te needle. We aspirated about 50 cc bone marrow from each subject.
Umbilical cord taking Right after the delivering the baby, the umbilical cord are cut and kept in a sterile bowl containing 0.9% NaCl in 40 until the sample is proceed.
Adipose taking Adipose tissue are derived from liposuction or open reduction internal fixation procedure. It is kept in a sterile bowl containing NaCL 0.9% in 40 C. Processing of the sample is done within 8 hours after sample are taken.
Cryopreservation and re activation. All the samples are taken to culture laboratory in integrated service of stem cell medical technology Cipto mangunkusumo hospita.this laboratory is GMP (good manufacturing Product) certified. The samples ate cultured in appropriated medium until it reach confluence and harvested. The cells then undergo caracterisation test by flow cyto meter and viability and numbers are counted. Some of the cells then cryopreserved while some are directly implanted into patient. The cells are cryopreserved for three months and then reactivated. Viability and numbers then are measured. The cells then are implanted to non union patient.
Specimen sterility Sterility tests are done three times to ensure there is no fungal and bacterial contamination.
HA-CaSO4 and MSC For every centimeter of defect, 10 millions cells and 50 pellet HA-CaSO4 are needed. The diluted MSC then mix with the HA-CaSO4 and incubated 5 minutes before implanted.
Intervention Surgical intervention is needed to assemble the fixation device in the long bone. During the surgery, pellet HA-CaSO4 are inserted into the defect. After soft tissue are closed the rest of the serum is injected into the defect area.
Observation and follow up Clinical and radiological follow up is done every 4 weeks. Observation is done for 12 months or untill the bone unites. Every subject will be followed up in the third, sixth, twelfth and twenty forth or until the fixation device is taken off.
Recipient criteria for non union fracture
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| implantation group | Experimental | Biological: MSCimplantation group will receive MSC and HA-CaSo4 |
Who may qualify
- Ages
- 19 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Bone marrow donor : Male/female aged 19-30 year without any comorbiditites (Diabetes mellitus, cardiovascular and any other autoimmune disease),HIV test Hepatitis B test and Hepatitis C test are negaitve, no fungal and bacterial contamination in the bone marrow. Subjects are willing to be aspiratied in the iliac crest in order to get the bone marrow.
- Adipose donor : Adipose tissue are gained from liposuction or open reduction internal fixation procedure. Samples of adipose are free from HIV, Hepatitis B, Hepatitis C and free from fungal and bacterial contamination.
- Umbilical cord donor : Umbilical cord are form elective seccio caecaria from a fullterm mother without any complications and free from HIV, hepatitis B, hepatitis C and no fungal and bacterial contamination.
Key exclusion criteria (3 listed)
- -Patients are ruled out from this study if he/she stated to do so in the time this research are held or she/he undergoes any other threatment that are not related to this study. Patient who does not show any clinical improvement in three consecutive months is categorized as failed to threat. All drop out and failed to threat patient could get other threatment.
- inclusion criteria for recipient : -male/female aged 6-55 year old with bone critical defect
- -Patients with pathological fracture caused by malignancy, immunocompromised ( HIV AIDS, Diabetes mellitus, active Hepatitis), in a immunosuppresant therapy ( chemotherapy or steroids).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MSCsubjects are implanted with allogenic mesenchymal stem cells from umbilical cord/ bone marrow/ adipose | Biological | implantation group |
Primary outcome
cell viability
Time frame: 3 months
percentage of cells that live divided by total cell
2 secondary outcomes
lower extremity functional score
Time frame: 3 months
disabilities of arm shoulder and hand
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2014.
- Background: PubMed 10602065Kon E, Muraglia A, Corsi A, Bianco P, Marcacci M, Martin I, Boyde A, Ruspantini I, Chistolini P, Rocca M, Giardino R, Cancedda R, Quarto R. Autologous bone marrow stromal cells loaded onto porous hydroxyapatite ceramic accelerate bone repair in critical-size defects of sheep long bones. J Biomed Mater Res. 2000 Mar 5;49(3):328-37. doi: 10.1002/(sici)1097-4636(20000305)49:33.0.co;2-q.
- Background: PubMed 20436013Hee HT, Ismail HD, Lim CT, Goh JC, Wong HK. Effects of implantation of bone marrow mesenchymal stem cells, disc distraction and combined therapy on reversing degeneration of the intervertebral disc. J Bone Joint Surg Br. 2010 May;92(5):726-36. doi: 10.1302/0301-620X.92B5.23015.
- Background: PubMed 19073406Ye Z, Wang Y, Xie HY, Zheng SS. Immunosuppressive effects of rat mesenchymal stem cells: involvement of CD4+CD25+ regulatory T cells. Hepatobiliary Pancreat Dis Int. 2008 Dec;7(6):608-14.
- Background: PubMed 16920750Bocelli-Tyndall C, Bracci L, Spagnoli G, Braccini A, Bouchenaki M, Ceredig R, Pistoia V, Martin I, Tyndall A. Bone marrow mesenchymal stromal cells (BM-MSCs) from healthy donors and auto-immune disease patients reduce the proliferation of autologous- and allogeneic-stimulated lymphocytes in vitro. Rheumatology (Oxford). 2007 Mar;46(3):403-8. doi: 10.1093/rheumatology/kel267. Epub 2006 Aug 18.
- Background: PubMed 16873762Yanez R, Lamana ML, Garcia-Castro J, Colmenero I, Ramirez M, Bueren JA. Adipose tissue-derived mesenchymal stem cells have in vivo immunosuppressive properties applicable for the control of the graft-versus-host disease. Stem Cells. 2006 Nov;24(11):2582-91. doi: 10.1634/stemcells.2006-0228. Epub 2006 Jul 27.
- Background: PubMed 20386557Tipnis S, Viswanathan C, Majumdar AS. Immunosuppressive properties of human umbilical cord-derived mesenchymal stem cells: role of B7-H1 and IDO. Immunol Cell Biol. 2010 Nov-Dec;88(8):795-806. doi: 10.1038/icb.2010.47. Epub 2010 Apr 13.
- Results publication: PubMed 24192520Hou ZL, Liu Y, Mao XH, Wei CY, Meng MY, Liu YH, Zhuyun Yang Z, Zhu H, Short M, Bernard C, Xiao ZC. Transplantation of umbilical cord and bone marrow-derived mesenchymal stem cells in a patient with relapsing-remitting multiple sclerosis. Cell Adh Migr. 2013 Sep-Oct;7(5):404-7. doi: 10.4161/cam.26941. Epub 2013 Oct 30.
- Results publication: PubMed 14960673Brinker MR, O'Connor DP. The incidence of fractures and dislocations referred for orthopaedic services in a capitated population. J Bone Joint Surg Am. 2004 Feb;86(2):290-7.
- Results publication: PubMed 23732992Liebergall M, Schroeder J, Mosheiff R, Gazit Z, Yoram Z, Rasooly L, Daskal A, Khoury A, Weil Y, Beyth S. Stem cell-based therapy for prevention of delayed fracture union: a randomized and prospective preliminary study. Mol Ther. 2013 Aug;21(8):1631-8. doi: 10.1038/mt.2013.109. Epub 2013 Jun 4.
- Results publication: PubMed 17383488Sen MK, Miclau T. Autologous iliac crest bone graft: should it still be the gold standard for treating nonunions? Injury. 2007 Mar;38 Suppl 1:S75-80. doi: 10.1016/j.injury.2007.02.012.
- Results publication: PubMed 9186204Goulet JA, Senunas LE, DeSilva GL, Greenfield ML. Autogenous iliac crest bone graft. Complications and functional assessment. Clin Orthop Relat Res. 1997 Jun;(339):76-81. doi: 10.1097/00003086-199706000-00011.
- Results publication: PubMed 15998219Mauney JR, Volloch V, Kaplan DL. Role of adult mesenchymal stem cells in bone tissue engineering applications: current status and future prospects. Tissue Eng. 2005 May-Jun;11(5-6):787-802. doi: 10.1089/ten.2005.11.787.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ISMAIL H DILOGO, MD principal investigator
integrated unit of stem cell and medical technology CIPTO MANGUNKUSUMO GENERAL HOSPITAL, FACULTY OF MEDICINE UNIVERSITI OF INDONESIA, INDONESIA
ismail h dilogo, MD principal investigator
Universitas Indonesia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing MSC in people with Non Union Fracture and Metaphyseal Fibrous Defect, run by Universitas Indonesia at 2 sites in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ISMAIL H DILOGO, MD, SPOT (+6221 44539917, ISMAILORTHOFKUI@YAHOO.CO.ID), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cell viability (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02307435, which also lists 38 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2014.