Degenerative ArthritisPhase 2/3NCT00891501
The Use of Autologous Bone Marrow Mesenchymal Stem Cells in the Treatment of Articular Cartilage Defects
A Phase 2/3 study testing Bone Marrow Aspiration and Bone marrow mesenchymal stem cell implantation in people with Degenerative Arthritis and Chondral Defects, run by Cairo University at 1 site in Egypt.
Trial summary
This study is conducted to assess whether implanting autologous, culture-expanded, mesenchymal stem cells obtained from the bone marrow of patients with early osteoarthritis, cartilage defects or cartilage and underlying bone and cartilage (osteochondral) defects in joints is effective in the treatment of such… Read more about this study
- Who is it for?
- Ages 15 to 55 years
- Conditions the study is for
- Degenerative Arthritis, Chondral Defects, Osteochondral Defects
- What is being tested?
- Bone Marrow Aspiration and Bone marrow mesenchymal stem cell implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2006to Dec 2014
- Phase
- Phase 2/3
- 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 15 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Active patients (15 to 55 years).
- An isolated osteochondral defect (i.e., in a joint with an otherwise healthy articular surface - with cartilage on the opposing surface no more than grade 1 or 2 Outerbridge at the most.
- A defect that is 1 - 4 cm2 or more (up to 16 cm2).
Who cannot join
- Patients younger than 15 years and older than 55 years.
- Diffuse and advanced articular cartilage degeneration of the joint
- Axial malalignment, meniscal pathology, and ligamentous instability are RELATIVE contraindications that have to be dealt with primarily either concomitantly or before the transplantation during 1 of the 2 stages of the procedure. Refusal of the patient to address these conditions in presence of a cartilage lesion is a criterion for exclusion from the study.
- Kissing lesions (i.e., on both opposing surfaces of a joint).
- Existing infection in or around the joint \& lesions of infectious or oncologic etiology.
- Debilitated patients.
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- Immunocompromised patients.
- Patients with autoimmune disorders \& systemic inflammatory disease.
- Preoperative poor neurological or vascular status of the affected limb.
- Specific contraindications include the use of tobacco and medications that may impair cell proliferation, such as NSAIDs and immunosuppressive drugs. Patients must be nicotine-free (stop smoking) prior to the procedure, as studies have shown that the oxidative effect of smoking impairs cell function and subsequent healing.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Deaprtment of Orthopedic Surgery and Tissue Culture Unit of the Department of Medical Biochemistry - Cairo University School of Medicne - Kasr Al Ainy Hospitals -Al-Saray Street, El Manial
Cairo, Cairo Governorate, 11956
Hazem Abdel Azeem, M.D, +(20)122127044, hazem@hazemabdelazeem.com
Hazem M Atta, Ph.D, +(20)123113378, hazemmahmoudatta@yahoo.ie
About this study
This study is conducted to assess whether implanting autologous, culture-expanded, mesenchymal stem cells obtained from the bone marrow of patients with early osteoarthritis, cartilage defects or cartilage and underlying bone and cartilage (osteochondral) defects in joints is effective in the treatment of such conditions and alleviation of patients symptoms.
Read the detailed description
All procedures are carried out after obtaining informed written consent from patients. Bone marrow is aspirated from the iliac crest (hip bone) of patients with osteochondral defects intraoperatively under complete sterile, aseptic conditions and under proper anaesthesia (general, local). The bone marrow aspirate is placed in tubes and transferred under aseptic conditions to the Tissue Culture Unit in the Biochemistry Department at the Cairo University School of Medicine where it is processed and bone marrow mesenchymal stem cells are isolated and grown in culture for 2-3 weeks. After this time interval, the cells are reprocessed and the cell pellet is obtained. Implantation of the cell pellet into the osteochondral defect of the joint after embedding it on a proper scaffold is performed followed by subsequent defect coverage with an autologous periosteal flap obtained from the proximal tibia to seal the defect and maintain the cell pellet in place. The patients will be assessed clinically with scoring systems preoperatively as well as 6 and 12 months postoperatively to assess relief of symptoms and joint function. Radiological assessment (X-rays and MRIs)of the affected joints will be performed at the same time points aforementioned to assess integrity of the formed cartilage. Second look arthroscopy and biopsy will also be performed to histologically assess the repair tissue and grade it via arthroscopic grading system according to the International Cartilage Repair Society guidelines.
- Being tested
- Bone Marrow Aspiration, Bone marrow mesenchymal stem cell implantation
- Keywords
- autologous bone marrow mesenchymal stem cells, cartilage repair, osteoarthritis, osteochondral defects
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone Marrow AspirationProcedure or surgery
Also called Bone marrow Biopsy
Autologous bone marrow is aspirated from the iliac crest (hip bone) of the patient using a 21-gauge bone marrow aspiration needle under complete aseptic conditions and proper anaesthesia
Bone marrow mesenchymal stem cell implantationProcedure or surgery
Also called Autologous stem cell implantation for cartilage repair
The culture expanded mesenchymal stem cell pellet will be implanted into the osteochondral knee defect via open surgery or arthroscopically under complete sterile aseptic conditions and proper anaesthesia. The defect will be covered with an autologous periosteal flap from the proximal tibia and then sealed with human fibrin glue to seal the defect and retain the cell pellet in place
| Study group | Role | What they receive |
|---|---|---|
| Single | Experimental | Clinical case series Receives: Procedure: Bone Marrow Aspiration; Procedure: Bone marrow mesenchymal stem cell implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Clinical Scores and Radiological images
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2009 (estimated)
- Study startNov 2006
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Degenerative ArthritisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Investigators
- Abdel Aziz El Singergy, M.D, Study director, Department of Orthopedic Surgery Cairo University School of MedicineAmgad M Haleem, M.Sc(Ortho), Principal investigator, Department of Orthopedic Surgery Cairo University School of MedicneHazem M Atta, Ph.D, Study director, Tissue Culture Unit - Department of Medical Biochemistry - Cairo University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00891501
- Sponsor's protocol ID
- Amgad
- Status last verified
- Apr 2009
- First submitted
- 30 Apr 2009
- Last updated
- 1 May 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Wakitani S, Goto T, Pineda SJ, Young RG, Mansour JM, Caplan AI, Goldberg VM. Mesenchymal cell-based repair of large, full-thickness defects of articular cartilage. J Bone Joint Surg Am. 1994 Apr;76(4):579-92. doi: 10.2106/00004623-199404000-00013.
PubMed 8150826Wakitani S, Mitsuoka T, Nakamura N, Toritsuka Y, Nakamura Y, Horibe S. Autologous bone marrow stromal cell transplantation for repair of full-thickness articular cartilage defects in human patellae: two case reports. Cell Transplant. 2004;13(5):595-600. doi: 10.3727/000000004783983747.
PubMed 15565871Kuroda R, Ishida K, Matsumoto T, Akisue T, Fujioka H, Mizuno K, Ohgushi H, Wakitani S, Kurosaka M. Treatment of a full-thickness articular cartilage defect in the femoral condyle of an athlete with autologous bone-marrow stromal cells. Osteoarthritis Cartilage. 2007 Feb;15(2):226-31. doi: 10.1016/j.joca.2006.08.008. Epub 2006 Sep 26.
PubMed 17002893
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Autologous Bone Marrow Mesenchymal Stem Cells in the Treatment of Articular Cartilage Defects
- ClinicalTrials.gov ID
- NCT00891501
- Acronym / sponsor ID
- Amgad
- Keywords
- autologous bone marrow mesenchymal stem cells, cartilage repair, osteoarthritis, osteochondral defects
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 1 May 2009 (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.
This study is conducted to assess whether implanting autologous, culture-expanded, mesenchymal stem cells obtained from the bone marrow of patients with early osteoarthritis, cartilage defects or cartilage and underlying bone and cartilage (osteochondral) defects in joints is effective in the treatment of such conditions and alleviation of patients symptoms.
Detailed description
All procedures are carried out after obtaining informed written consent from patients. Bone marrow is aspirated from the iliac crest (hip bone) of patients with osteochondral defects intraoperatively under complete sterile, aseptic conditions and under proper anaesthesia (general, local). The bone marrow aspirate is placed in tubes and transferred under aseptic conditions to the Tissue Culture Unit in the Biochemistry Department at the Cairo University School of Medicine where it is processed and bone marrow mesenchymal stem cells are isolated and grown in culture for 2-3 weeks. After this time interval, the cells are reprocessed and the cell pellet is obtained. Implantation of the cell pellet into the osteochondral defect of the joint after embedding it on a proper scaffold is performed followed by subsequent defect coverage with an autologous periosteal flap obtained from the proximal tibia to seal the defect and maintain the cell pellet in place. The patients will be assessed clinically with scoring systems preoperatively as well as 6 and 12 months postoperatively to assess relief of symptoms and joint function. Radiological assessment (X-rays and MRIs)of the affected joints will be performed at the same time points aforementioned to assess integrity of the formed cartilage. Second look arthroscopy and biopsy will also be performed to histologically assess the repair tissue and grade it via arthroscopic grading system according to the International Cartilage Repair Society guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single | Experimental | Procedure: Bone Marrow Aspiration, Procedure: Bone marrow mesenchymal stem cell implantationClinical case series |
Who may qualify
- Ages
- 15 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Active patients (15 to 55 years).
- An isolated osteochondral defect (i.e., in a joint with an otherwise healthy articular surface - with cartilage on the opposing surface no more than grade 1 or 2 Outerbridge at the most.
- A defect that is 1 - 4 cm2 or more (up to 16 cm2).
Key exclusion criteria (10 listed)
- Patients younger than 15 years and older than 55 years.
- Diffuse and advanced articular cartilage degeneration of the joint
- Axial malalignment, meniscal pathology, and ligamentous instability are RELATIVE contraindications that have to be dealt with primarily either concomitantly or before the transplantation during 1 of the 2 stages of the procedure. Refusal of the patient to address these conditions in presence of a cartilage lesion is a criterion for exclusion from the study.
- Kissing lesions (i.e., on both opposing surfaces of a joint).
- Existing infection in or around the joint \& lesions of infectious or oncologic etiology.
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 |
|---|---|---|
| Bone Marrow AspirationAlso: Bone marrow BiopsyAutologous bone marrow is aspirated from the iliac crest (hip bone) of the patient using a 21-gauge bone marrow aspiration needle under complete aseptic conditions and proper anaesthesia | Procedure or surgery | Single |
| Bone marrow mesenchymal stem cell implantationAlso: Autologous stem cell implantation for cartilage repairThe culture expanded mesenchymal stem cell pellet will be implanted into the osteochondral knee defect via open surgery or arthroscopically under complete sterile aseptic conditions and proper anaesthesia. The defect will be covered with an autologous periosteal flap from the proximal tibia and then sealed with human fibrin glue to seal the defect and retain the cell pellet in place | Procedure or surgery | Single |
Primary outcome
Improvement in Clinical Scores and Radiological images
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2009.
- Results publication: PubMed 8150826Wakitani S, Goto T, Pineda SJ, Young RG, Mansour JM, Caplan AI, Goldberg VM. Mesenchymal cell-based repair of large, full-thickness defects of articular cartilage. J Bone Joint Surg Am. 1994 Apr;76(4):579-92. doi: 10.2106/00004623-199404000-00013.
- Results publication: PubMed 15565871Wakitani S, Mitsuoka T, Nakamura N, Toritsuka Y, Nakamura Y, Horibe S. Autologous bone marrow stromal cell transplantation for repair of full-thickness articular cartilage defects in human patellae: two case reports. Cell Transplant. 2004;13(5):595-600. doi: 10.3727/000000004783983747.
- Results publication: PubMed 17002893Kuroda R, Ishida K, Matsumoto T, Akisue T, Fujioka H, Mizuno K, Ohgushi H, Wakitani S, Kurosaka M. Treatment of a full-thickness articular cartilage defect in the femoral condyle of an athlete with autologous bone-marrow stromal cells. Osteoarthritis Cartilage. 2007 Feb;15(2):226-31. doi: 10.1016/j.joca.2006.08.008. Epub 2006 Sep 26.
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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.
Abdel Aziz El Singergy, M.D study director
Department of Orthopedic Surgery Cairo University School of Medicine
Amgad M Haleem, M.Sc(Ortho) principal investigator
Department of Orthopedic Surgery Cairo University School of Medicne
Hazem M Atta, Ph.D study director
Tissue Culture Unit - Department of Medical Biochemistry - Cairo University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Bone Marrow Aspiration and Bone marrow mesenchymal stem cell implantation in people with Degenerative Arthritis and Chondral Defects, run by Cairo University at 1 site in Egypt.
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 10 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 1 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Amgad M. Haleem, M.Sc (Ortho) ((+1) 980-230-8310, amgad_haleem@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Clinical Scores and Radiological images (time frame: 1 year). 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 NCT00891501, which also lists 3 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 1 May 2009.