Bone Loss in JawNCT05241548
BMAC on PCL Scaffold for Ridge Augmentation
A study testing BMAC on PCL Scaffold in people with Bone Loss in Jaw and Edentulous Alveolar Ridge, run by Cairo University at 1 site in Egypt.
Trial summary
BMAC is used on 3D printed PCL scaffold for horizontal ridge augmentation in aesthetic zone , BMAC contains MSCs which can differentiate in osteogenic medium into osteoblasts which can lay down bone Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Loss in Jaw, Edentulous Alveolar Ridge
- What is being tested?
- BMAC on PCL Scaffold
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2022to 1 Dec 2023
- Phase
- Interventional
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient who require horizontal ridge augmentation in the aesthetic zone (Maxillary anterior and premolar area) with defect size of one or two lost teeth.
- Patients in the age range of 18 years and above.
- ASA physical status I and II.
- Patients willing to be a part of the study and ready to give their consent in writing for the same.
Who cannot join
- Local criteria:
- Untreated gingivitis, periodontitis.
- Insufficient oral hygiene.
- Previous radiation therapy the head and neck neoplasia, or bone augmentation to implant site.
- Systemic criteria:
- Systemic disorders.
- Smoking.
- Bone pathology.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bone Marrow Aspirate Concentrate(BMAC) on 3D Printed Polycaprolactone (PCL) Scaffold for Ridge Augmentation of Horizontal Alveolar Defects in Aesthetic Zone (Clinical Case Series Study)
BMAC is used on 3D printed PCL scaffold for horizontal ridge augmentation in aesthetic zone , BMAC contains MSCs which can differentiate in osteogenic medium into osteoblasts which can lay down bone
Read the detailed description
Alveolar bone defects were classified according to their morphology and pattern of bone loss into Class I where buccolingual loss occurs while maintaining the vertical height( Horizontal defect), Class II where vertical bone loss occurs with no buccolingual width loss (Vertical defect) and Class III where combination of vertical and horizontal bone loss occurs . These defects require augmentation before implant placement, several techniques were approached including autogenous and non autogenous bone grafting , Guided bone regeneration (GBR), ridge splitting and distraction osteogenesis. Bone grafts used with these techniques are categorized into : autografts, allografts , xenografts and alloplasts.
Autogenous bone is considered to be the gold standard in grafting because it is osteogenic in nature, osteoinductive , osteoconductive and immunologically safe The autogenous bone can be harvested intraorally from the chin area, mandibular ramus, retromolar area, maxillary tuberosity, Coronoid process, zygomatic bone or palatal and mandibular tori if present . Intraoral harvesting has the advantage of good access and no need for hospitalization but the main disadvantage is the donor site morbidity and the small amount of harvested bone. Extraoral harvesting sites include the ilium, calvarium, ribs, tibia and fibula. Extraoral harvesting solved the problem of the limited amount of harvested bone graft but the main disadvantages are the need of hospitalization, performing the harvesting procedure under general anesthesia and high morbidity due to the second surgical site Recently, tissue engineering has been used for bone regeneration so called bone tissue engineering (BTE) which aims to combine the progenitor cells to differentiate into osteoblasts, growth factors needed for regenerative process and osteoconductive scaffolds for therapeutic applications. BTE involves harvesting osteogenic cells from an autologous harvesting site ( bone marrow or adipose tissue) and/or ex vivo amplification and seeding the scaffold with cells for in vivo implantation aiming to replicate the properties of autogenous bone and decrease the need for invasive harvesting Bone marrow contains a heterogenous population of progenitor cells such as Mesenchymal stem cells (MSC),hematopoietic stem cells (HSC) and endothelial progenitor cells in addition to several growth factors, including platelet-derived growth factor (PDGF), transforming growth factor-beta (TGF-b), and bone morphogenetic protein (BMP)-2 and BMP-7, which are known to have anabolic and anti-inflammatory effects. Concentration of the mononuclear cell fraction (MNC) of bone marrow aspirate ( which includes MSCs) by density gradient centrifugation process to remove erythrocytes, granulocytes, platelets and immature myeloid precursors to form Bone Marrow Aspirate Concentrate (BMAC) is considered important step in BTE. .
Many clinical studies proved the use of Bone Marrow Aspirate Concentrate for treatment of osseous defects and cartilage defects due to the ability of MSCs to differentiate into osteoblasts, chondroblasts or adipocytes.
The mesenchymal stem cells (MSCs) are highly biologically competent as they possess the ability to adhere on plastic (scaffolds) in vitro, form colony forming fibroblasts (CFU) and differentiate into mesenchyme lineages ( adipocytes, osteocytes, chondrocytes, tenocytes, myocytes) in addition to their potential of self renewal and promotion of hematopoiesis. Also, they suppress alloresponse after transplantation .
Scaffolds are support structures used in tissue engineering to allow 3D growth of cells in an organized way and can be classified into natural (such as collagen plug) , synthetic aliphatic polyesters such as polycaprolactone (PCL), polyglycolic acid (PGA) and polylactic acid (PLA) and their copolymers and derivatives and composite scaffold which are made by combining bioceramics with polymers or xenogenic biomaterials together with bioceramics or polymers .
- Conditions
- Bone Loss in Jaw, Edentulous Alveolar Ridge
- Being tested
- BMAC on PCL Scaffold
- Keywords
- Ridge augmentation, BMAC , PCL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMAC on PCL ScaffoldProcedure or surgery
Horizontal ridge augmentation in aesthetic zone by using bone marrow aspirate concentrate on PCL scaffold
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Ridge augmentation of horizontally deficient alveolar ridge in aesthetic zone by BMAC on PCL scaffold Receives: Procedure: BMAC on PCL Scaffold |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Width gain
The width of the augmented alveolar ridge measured from the Cone Beam Computed Tomography in millimeters
Measured: 6 months
Secondary outcomes (1)
Percentage of bone formation in the bone biopsy
Bone biopsy is obtained after 6 months and subjected to histomorphometric analysis
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start15 Jan 2022
- Primary completion1 Jun 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Bone Loss in JawStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Aly Hassan Fouad, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05241548
- Sponsor's protocol ID
- BMAC 3D PCL
- Status last verified
- Jan 2026
- First submitted
- 15 Jan 2022
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chahla J, Dean CS, Moatshe G, Pascual-Garrido C, Serra Cruz R, LaPrade RF. Concentrated Bone Marrow Aspirate for the Treatment of Chondral Injuries and Osteoarthritis of the Knee: A Systematic Review of Outcomes. Orthop J Sports Med. 2016 Jan 13;4(1):2325967115625481. doi: 10.1177/2325967115625481. eCollection 2016 Jan.
PubMed 26798765Cotter EJ, Wang KC, Yanke AB, Chubinskaya S. Bone Marrow Aspirate Concentrate for Cartilage Defects of the Knee: From Bench to Bedside Evidence. Cartilage. 2018 Apr;9(2):161-170. doi: 10.1177/1947603517741169. Epub 2017 Nov 10.
PubMed 29126349Dominici M, Le Blanc K, Mueller I, Slaper-Cortenbach I, Marini F, Krause D, Deans R, Keating A, Prockop Dj, Horwitz E. Minimal criteria for defining multipotent mesenchymal stromal cells. The International Society for Cellular Therapy position statement. Cytotherapy. 2006;8(4):315-7. doi: 10.1080/14653240600855905.
PubMed 16923606Jager M, Jelinek EM, Wess KM, Scharfstadt A, Jacobson M, Kevy SV, Krauspe R. Bone marrow concentrate: a novel strategy for bone defect treatment. Curr Stem Cell Res Ther. 2009 Jan;4(1):34-43. doi: 10.2174/157488809787169039.
PubMed 19149628McAllister BS, Haghighat K. Bone augmentation techniques. J Periodontol. 2007 Mar;78(3):377-96. doi: 10.1902/jop.2007.060048.
PubMed 17335361Sanz M, Dahlin C, Apatzidou D, Artzi Z, Bozic D, Calciolari E, De Bruyn H, Dommisch H, Donos N, Eickholz P, Ellingsen JE, Haugen HJ, Herrera D, Lambert F, Layrolle P, Montero E, Mustafa K, Omar O, Schliephake H. Biomaterials and regenerative technologies used in bone regeneration in the craniomaxillofacial region: Consensus report of group 2 of the 15th European Workshop on Periodontology on Bone Regeneration. J Clin Periodontol. 2019 Jun;46 Suppl 21:82-91. doi: 10.1111/jcpe.13123.
PubMed 31215114Seibert JS. Reconstruction of deformed, partially edentulous ridges, using full thickness onlay grafts. Part I. Technique and wound healing. Compend Contin Educ Dent (Lawrenceville). 1983 Sep-Oct;4(5):437-53. No abstract available.
PubMed 6578906Seibert JS. Reconstruction of deformed, partially edentulous ridges, using full thickness onlay grafts. Part II. Prosthetic/periodontal interrelationships. Compend Contin Educ Dent (Lawrenceville). 1983 Nov-Dec;4(6):549-62. No abstract available.
PubMed 6321099Shanbhag S, Suliman S, Pandis N, Stavropoulos A, Sanz M, Mustafa K. Cell therapy for orofacial bone regeneration: A systematic review and meta-analysis. J Clin Periodontol. 2019 Jun;46 Suppl 21:162-182. doi: 10.1111/jcpe.13049.
PubMed 30623455
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Marrow Aspirate Concentrate(BMAC) on 3D Printed Polycaprolactone (PCL) Scaffold for Ridge Augmentation of Horizontal Alveolar Defects in Aesthetic Zone (Clinical Case Series Study)
- ClinicalTrials.gov ID
- NCT05241548
- Acronym / sponsor ID
- BMAC 3D PCL
- Conditions
- Bone Loss in Jaw, Edentulous Alveolar Ridge
- Keywords
- Ridge augmentation, BMAC , PCL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 15 Feb 2022 (actual)
- 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.
BMAC is used on 3D printed PCL scaffold for horizontal ridge augmentation in aesthetic zone , BMAC contains MSCs which can differentiate in osteogenic medium into osteoblasts which can lay down bone
Detailed description
Alveolar bone defects were classified according to their morphology and pattern of bone loss into Class I where buccolingual loss occurs while maintaining the vertical height( Horizontal defect), Class II where vertical bone loss occurs with no buccolingual width loss (Vertical defect) and Class III where combination of vertical and horizontal bone loss occurs . These defects require augmentation before implant placement, several techniques were approached including autogenous and non autogenous bone grafting , Guided bone regeneration (GBR), ridge splitting and distraction osteogenesis. Bone grafts used with these techniques are categorized into : autografts, allografts , xenografts and alloplasts.
Autogenous bone is considered to be the gold standard in grafting because it is osteogenic in nature, osteoinductive , osteoconductive and immunologically safe The autogenous bone can be harvested intraorally from the chin area, mandibular ramus, retromolar area, maxillary tuberosity, Coronoid process, zygomatic bone or palatal and mandibular tori if present . Intraoral harvesting has the advantage of good access and no need for hospitalization but the main disadvantage is the donor site morbidity and the small amount of harvested bone. Extraoral harvesting sites include the ilium, calvarium, ribs, tibia and fibula. Extraoral harvesting solved the problem of the limited amount of harvested bone graft but the main disadvantages are the need of hospitalization, performing the harvesting procedure under general anesthesia and high morbidity due to the second surgical site Recently, tissue engineering has been used for bone regeneration so called bone tissue engineering (BTE) which aims to combine the progenitor cells to differentiate into osteoblasts, growth factors needed for regenerative process and osteoconductive scaffolds for therapeutic applications. BTE involves harvesting osteogenic cells from an autologous harvesting site ( bone marrow or adipose tissue) and/or ex vivo amplification and seeding the scaffold with cells for in vivo implantation aiming to replicate the properties of autogenous bone and decrease the need for invasive harvesting Bone marrow contains a heterogenous population of progenitor cells such as Mesenchymal stem cells (MSC),hematopoietic stem cells (HSC) and endothelial progenitor cells in addition to several growth factors, including platelet-derived growth factor (PDGF), transforming growth factor-beta (TGF-b), and bone morphogenetic protein (BMP)-2 and BMP-7, which are known to have anabolic and anti-inflammatory effects. Concentration of the mononuclear cell fraction (MNC) of bone marrow aspirate ( which includes MSCs) by density gradient centrifugation process to remove erythrocytes, granulocytes, platelets and immature myeloid precursors to form Bone Marrow Aspirate Concentrate (BMAC) is considered important step in BTE. .
Many clinical studies proved the use of Bone Marrow Aspirate Concentrate for treatment of osseous defects and cartilage defects due to the ability of MSCs to differentiate into osteoblasts, chondroblasts or adipocytes.
The mesenchymal stem cells (MSCs) are highly biologically competent as they possess the ability to adhere on plastic (scaffolds) in vitro, form colony forming fibroblasts (CFU) and differentiate into mesenchyme lineages ( adipocytes, osteocytes, chondrocytes, tenocytes, myocytes) in addition to their potential of self renewal and promotion of hematopoiesis. Also, they suppress alloresponse after transplantation .
Scaffolds are support structures used in tissue engineering to allow 3D growth of cells in an organized way and can be classified into natural (such as collagen plug) , synthetic aliphatic polyesters such as polycaprolactone (PCL), polyglycolic acid (PGA) and polylactic acid (PLA) and their copolymers and derivatives and composite scaffold which are made by combining bioceramics with polymers or xenogenic biomaterials together with bioceramics or polymers .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Procedure: BMAC on PCL ScaffoldRidge augmentation of horizontally deficient alveolar ridge in aesthetic zone by BMAC on PCL scaffold |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patient who require horizontal ridge augmentation in the aesthetic zone (Maxillary anterior and premolar area) with defect size of one or two lost teeth.
- Patients in the age range of 18 years and above.
- ASA physical status I and II.
- Patients willing to be a part of the study and ready to give their consent in writing for the same.
Key exclusion criteria (8 listed)
- Local criteria:
- Systemic disorders.
- Smoking.
- Bone pathology.
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 |
|---|---|---|
| BMAC on PCL ScaffoldHorizontal ridge augmentation in aesthetic zone by using bone marrow aspirate concentrate on PCL scaffold | Procedure or surgery | Intervention Group |
Primary outcome
Bone Width gain
Time frame: 6 months
The width of the augmented alveolar ridge measured from the Cone Beam Computed Tomography in millimeters
1 secondary outcome
Percentage of bone formation in the bone biopsy
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Background: PubMed 26798765Chahla J, Dean CS, Moatshe G, Pascual-Garrido C, Serra Cruz R, LaPrade RF. Concentrated Bone Marrow Aspirate for the Treatment of Chondral Injuries and Osteoarthritis of the Knee: A Systematic Review of Outcomes. Orthop J Sports Med. 2016 Jan 13;4(1):2325967115625481. doi: 10.1177/2325967115625481. eCollection 2016 Jan.
- Background: PubMed 29126349Cotter EJ, Wang KC, Yanke AB, Chubinskaya S. Bone Marrow Aspirate Concentrate for Cartilage Defects of the Knee: From Bench to Bedside Evidence. Cartilage. 2018 Apr;9(2):161-170. doi: 10.1177/1947603517741169. Epub 2017 Nov 10.
- Background: PubMed 16923606Dominici M, Le Blanc K, Mueller I, Slaper-Cortenbach I, Marini F, Krause D, Deans R, Keating A, Prockop Dj, Horwitz E. Minimal criteria for defining multipotent mesenchymal stromal cells. The International Society for Cellular Therapy position statement. Cytotherapy. 2006;8(4):315-7. doi: 10.1080/14653240600855905.
- Background: PubMed 19149628Jager M, Jelinek EM, Wess KM, Scharfstadt A, Jacobson M, Kevy SV, Krauspe R. Bone marrow concentrate: a novel strategy for bone defect treatment. Curr Stem Cell Res Ther. 2009 Jan;4(1):34-43. doi: 10.2174/157488809787169039.
- Background: PubMed 17335361McAllister BS, Haghighat K. Bone augmentation techniques. J Periodontol. 2007 Mar;78(3):377-96. doi: 10.1902/jop.2007.060048.
- Background: PubMed 31215114Sanz M, Dahlin C, Apatzidou D, Artzi Z, Bozic D, Calciolari E, De Bruyn H, Dommisch H, Donos N, Eickholz P, Ellingsen JE, Haugen HJ, Herrera D, Lambert F, Layrolle P, Montero E, Mustafa K, Omar O, Schliephake H. Biomaterials and regenerative technologies used in bone regeneration in the craniomaxillofacial region: Consensus report of group 2 of the 15th European Workshop on Periodontology on Bone Regeneration. J Clin Periodontol. 2019 Jun;46 Suppl 21:82-91. doi: 10.1111/jcpe.13123.
- Background: PubMed 6578906Seibert JS. Reconstruction of deformed, partially edentulous ridges, using full thickness onlay grafts. Part I. Technique and wound healing. Compend Contin Educ Dent (Lawrenceville). 1983 Sep-Oct;4(5):437-53. No abstract available.
- Background: PubMed 6321099Seibert JS. Reconstruction of deformed, partially edentulous ridges, using full thickness onlay grafts. Part II. Prosthetic/periodontal interrelationships. Compend Contin Educ Dent (Lawrenceville). 1983 Nov-Dec;4(6):549-62. No abstract available.
- Background: PubMed 30623455Shanbhag S, Suliman S, Pandis N, Stavropoulos A, Sanz M, Mustafa K. Cell therapy for orofacial bone regeneration: A systematic review and meta-analysis. J Clin Periodontol. 2019 Jun;46 Suppl 21:162-182. doi: 10.1111/jcpe.13049.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BMAC on PCL Scaffold in people with Bone Loss in Jaw and Edentulous Alveolar Ridge, 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 4 inclusion and 8 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: finished, as of the sponsor's last update on 21 Jan 2026. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Width gain (time frame: 6 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 NCT05241548, which also lists 9 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 21 Jan 2026.