To quantify the MSC population of concentrated bone marrow aspirate and examine their differential potentials and the variation among patients and examine similarities and differences with the current literature.
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Avarage number of stem cells available in a bone marrow aspirate and the
different cell typesin %.
Secondary outcome
Number of stem cells with bone or vascular generating potentials (through:
CD34, CD45, CD90, CD105, CD146, CD271 markers)
Colony forming potentials of stem cells (through CFU-F analysis)
Genexpressie of the osteoprogenitors (through PCR analyse)
Other baseline parameters will be noted to detect potential confounders: sex,
smoking, current diets, age and body weight.
Study parameters will be compared between patients and also to the existing
literature.
Background summary
Bone marrow cells (BMC) are rich of mesenchymal stem cells (MSC). These MSCs do
have clinical potential in orthopaedics because they give rise to the cells
that form mesenchymal tissues like bone and cartilage and they can be easily
obtained and concentrated from bone marrow. Only little evidence is available
of its content and the constancy of it among different patients, though
research suggest a correlation between amount of progenitor cells and healing
potentials of bone marrow aspirate at the affected area.
Study objective
To quantify the MSC population of concentrated bone marrow aspirate and examine
their differential potentials and the variation among patients and examine
similarities and differences with the current literature.
Study design
Non-invasive observational pilot study.
Bone marrow aspirate will be collected of 10 patients who suffer from a
bonedefect wherefor they need a autologous cancellous bone graft of the
anterior iliac crest (under general anesthesia).
If these patients meet all established criteria, they will be informed about
the research and sign the informed consent form if they want to participate.
During the surgery when bone graft is obtained, we use this route to aspirate
30cc bone marrow. The surgical procedure will continue directly after this. The
local researcher will perform the other procedures and then transport the
aspirate to the laboratory where the analysis will be performed. There will be
no follow-up of the patients.
Composition will be examined and results will be noted and compared to the
existing literature and mutually between patients.
Study burden and risks
This non-therapeutic research is of minor/negligible burden for the patient.
Because the osteogenic quality of bone marrow aspirates and its consistency
between patients is barely studied before, this can give us a great amount of
new and usefull information for future stem cell therapies in orthopedic
surgery, like non-union and fracture healing or prevention of osteoarthritis.
The risk to the patient can be considered minimal and the benefits of knowing
more about the basic qualities of bone marrow aspirates in orthopaedics would
greatly benefit its potentials and value in clinical orthopaedic population.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Patients
- in need of an autologous bone graft harvested of the (anterior or posterior) iliac crest for orthopaedic reason;
- understand study proposal and sign informed consent;
- > 18 years old
Exclusion criteria
Subjects:
- participating in other studies
- suffering from an autoimmune disease
- suffering from an infection
- suffering from a malignancy
- receiving or received chemotherapy / other bone marrow suppression medicine < 1 year ago
- suffering or suffered from a hematopoietic disease < 1 year ago
- an other known malignancy
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL47846.018.14 |