Pseudoarthrosis of BonePhase 1/2MSCNCT06103396
Treatment of Nonunion Fractures With Mesenchymal Stromal Cells (MSCs)
A Phase 1/2 study testing Transplantation of autologous MSCs in nonunion fracture and Transplantation of allogeneic MSCs in nonunion fracture in people with Pseudoarthrosis of Bone and Pseudarthrosis, run by Instituto Venezolano de Investigaciones Cientificas at 1 site in Venezuela.
Trial summary
The goal of this study is to evaluate the bone regeneration capacity of BM-MSC (Bone marrow mesenchymal stromal cells), in patients with nonunion. BM-MSC cultured are seeded on a collagen scaffold, included into autologous platelet-rich plasma (PRP) clot, and implanted in the nonunion bone defect. Read more about this study
- Who is it for?
- Ages 10 to 85 years
- Conditions the study is for
- Pseudoarthrosis of Bone, Pseudarthrosis, Non Union Fracture
- What is being tested?
- Transplantation of autologous MSCs in nonunion fracture and Transplantation of allogeneic MSCs in nonunion fracture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteVenezuela
- Study dates
- 30 Jan 2018to 30 Dec 2024
- Phase
- Phase 1/2
- 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 10 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Post-traumatic nonunion diagnosis (Pseudoarthrosis) with or without previous ortopaedic treatment
- Patients with or without previous orthopaedic treatment
- Presence of nonunion 9 month or more
- Ossification failure in the non-union area, with an approximate size of 0.5 to 4 cm length
Who cannot join
- Evidence of infection at the nonunion site (Osteomielitis)
- Evidence of cutaneous lesion at the site of pseudoartrosis
- Viral hepatitis B and C, HIV infection, syphilis and other viral and bacterial infections
- Autoimmune diseases
- Neoplastic diseases
- Pregnancy
Show all 9Show fewer
- Major metabolic disorders
- Treatment with steroids
- Other conditions or circumstances that compromise the study participation according to medical criteria
Trial locations and contacts
1 site in 1 country.
Venezuela1 site
Instituto Venezolano de Investigaciones Cientificas
Caracas, Miranda, 1204
About this study
Official title: Treatment of Nonunion After Fractures (Pseudoartrosis) Using Mesenchymal Stromal Cells (MSCs)
The goal of this study is to evaluate the bone regeneration capacity of BM-MSC (Bone marrow mesenchymal stromal cells), in patients with nonunion. BM-MSC cultured are seeded on a collagen scaffold, included into autologous platelet-rich plasma (PRP) clot, and implanted in the nonunion bone defect.
Read the detailed description
Nonunion (pseudoarthrosis) is one of the most serious complications of bone fracture. Even though different treatments have been used to repair nonunion bone defects, most of them have limitations, like morbidities, limited supply, frequent treatment failure, and high cost.
Based on the knowledge that MSC have multipotential capacity of differentiation into bone, cartilage, fat, and endothelial cells, and also, play a key role in the process of bone formation and fracture repair. In this study, we evaluated the use the bone regeneration capacity of autologous or allogeneic BM-MSC, as a potential therapeutic strategy to induce formation of new bone tissue and fracture healing.
A bioengineering construct, constituted by MSCs and a collagen scaffold, is incorporated into platelet rich plasma (PRP) clot, wich is implanted at the nonunion site defect.
- Being tested
- Transplantation of autologous MSCs in nonunion fracture, Transplantation of allogeneic MSCs in nonunion fracture
- Medical subject headings
- Pseudarthrosis, Fractures, Ununited
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transplantation of autologous MSCs in nonunion fractureBiological
At surgery, fibrotic tissue is removed from the nonunion sites. MSCs/Col/PRP clots are implanted in the site of nonunion.
Patients received conventional orthopedic treatment as they needed (osteotomy, external and/or internal fixation systems, etc.)
Transplantation of allogeneic MSCs in nonunion fractureBiological
At surgery, fibrotic tissue is removed from the nonunion sites. MSCs/Col/PRP clots are implanted in the site of nonunion.
Patients received conventional orthopedic treatment as they needed (osteotomy, external and/or internal fixation systems, etc.)
| Study group | Role | What they receive |
|---|---|---|
| Autologuos MSCs transplantation in nonunion defects | Experimental | Autologuos MSCs harvested and cultured in osteogenic medium are seeded on collagen scaffold, and mixed with autologous rich plasma clot. The MSCs construct (MSCs/Col/PRP clot), is implanted in the nonunion defect. Receives: Biological: Transplantation of autologous MSCs in nonunion fracture |
| Allogeneic MSCs transplantation in nonunion defects | Experimental | Allogeneic MSCs harvested and cultured in osteogenic medium are seeded on collagen scaffold, and mixed with autologous rich plasma clot. The MSCs construct (MSCs/Col/PRP clot), is implanted in the nonunion defect. Receives: Biological: Transplantation of allogeneic MSCs in nonunion fracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical evaluation
Time of surgical wound evolution, surgically intervened limb evolution, movility
Measured: Baseline, 1 and 7 days. 1, 2 and 6 months. 1 and 2 years
Bone consolidation
Time of development changes in bone consolidation by radiological studies
Measured: Baseline, 1 and 7 days. 1, 2 and 6 months. 1 and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start30 Jan 2018
- Primary completion30 Jan 2022
- Study completion30 Dec 2024 (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 Pseudoarthrosis of BoneStudies 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
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Venezolano de Investigaciones Cientificas
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Central Dr. Plácido D. Rodriguez Rivero, Instituto Autónomo Hospital Universitario de la Universidad de Los Andes
- Responsible party
- Principal investigator, Dylana Diaz Solano, Instituto Venezolano de Investigaciones Cientificas
- Investigators
- Jose E Cardier Montalvo, MD, PhD, Study chair, Instituto Venezolano de Investigaciones Cientificas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06103396
- Sponsor's protocol ID
- IVIC-UTC-MSC-Pseudarthrosis
- Acronym
- MSC
- Status last verified
- Oct 2023
- First submitted
- 23 Oct 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wittig O, Romano E, Gonzalez C, Diaz-Solano D, Marquez ME, Tovar P, Aoun R, Cardier JE. A method of treatment for nonunion after fractures using mesenchymal stromal cells loaded on collagen microspheres and incorporated into platelet-rich plasma clots. Int Orthop. 2016 May;40(5):1033-8. doi: 10.1007/s00264-016-3130-6. Epub 2016 Mar 16.
PubMed 26980620Wittig O, Diaz-Solano D, Cardier J. Viability and functionality of mesenchymal stromal cells loaded on collagen microspheres and incorporated into plasma clots for orthopaedic application: Effect of storage conditions. Injury. 2018 Jun;49(6):1052-1057. doi: 10.1016/j.injury.2018.04.005. Epub 2018 Apr 5.
PubMed 29678307Diaz-Solano D, Wittig O, Mota JD, Cardier JE. Isolation and Characterization of Multipotential Mesenchymal Stromal Cells from Congenital Pseudoarthrosis of the Tibia: Case Report. Anat Rec (Hoboken). 2015 Oct;298(10):1804-14. doi: 10.1002/ar.23198. Epub 2015 Jul 30.
PubMed 26194170
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Nonunion After Fractures (Pseudoartrosis) Using Mesenchymal Stromal Cells (MSCs)
- ClinicalTrials.gov ID
- NCT06103396
- Acronym / sponsor ID
- MSC / IVIC-UTC-MSC-Pseudarthrosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Instituto Venezolano de Investigaciones CientificasUniversity, hospital or other
- Collaborators
- Hospital Central Dr. Plácido D. Rodriguez Rivero, Instituto Autónomo Hospital Universitario de la Universidad de Los Andes
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 26 Oct 2023 (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.
The goal of this study is to evaluate the bone regeneration capacity of BM-MSC (Bone marrow mesenchymal stromal cells), in patients with nonunion. BM-MSC cultured are seeded on a collagen scaffold, included into autologous platelet-rich plasma (PRP) clot, and implanted in the nonunion bone defect.
Detailed description
Nonunion (pseudoarthrosis) is one of the most serious complications of bone fracture. Even though different treatments have been used to repair nonunion bone defects, most of them have limitations, like morbidities, limited supply, frequent treatment failure, and high cost.
Based on the knowledge that MSC have multipotential capacity of differentiation into bone, cartilage, fat, and endothelial cells, and also, play a key role in the process of bone formation and fracture repair. In this study, we evaluated the use the bone regeneration capacity of autologous or allogeneic BM-MSC, as a potential therapeutic strategy to induce formation of new bone tissue and fracture healing.
A bioengineering construct, constituted by MSCs and a collagen scaffold, is incorporated into platelet rich plasma (PRP) clot, wich is implanted at the nonunion site defect.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autologuos MSCs transplantation in nonunion defects | Experimental | Biological: Transplantation of autologous MSCs in nonunion fractureAutologuos MSCs harvested and cultured in osteogenic medium are seeded on collagen scaffold, and mixed with autologous rich plasma clot. The MSCs construct (MSCs/Col/PRP clot), is implanted in the nonunion defect. |
| Allogeneic MSCs transplantation in nonunion defects | Experimental | Biological: Transplantation of allogeneic MSCs in nonunion fractureAllogeneic MSCs harvested and cultured in osteogenic medium are seeded on collagen scaffold, and mixed with autologous rich plasma clot. The MSCs construct (MSCs/Col/PRP clot), is implanted in the nonunion defect. |
Who may qualify
- Ages
- 10 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Post-traumatic nonunion diagnosis (Pseudoarthrosis) with or without previous ortopaedic treatment
- Patients with or without previous orthopaedic treatment
- Presence of nonunion 9 month or more
- Ossification failure in the non-union area, with an approximate size of 0.5 to 4 cm length
Key exclusion criteria (9 listed)
- Evidence of infection at the nonunion site (Osteomielitis)
- Evidence of cutaneous lesion at the site of pseudoartrosis
- Viral hepatitis B and C, HIV infection, syphilis and other viral and bacterial infections
- Autoimmune diseases
- Neoplastic diseases
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 |
|---|---|---|
| Transplantation of autologous MSCs in nonunion fractureAt surgery, fibrotic tissue is removed from the nonunion sites. MSCs/Col/PRP clots are implanted in the site of nonunion. Patients received conventional orthopedic treatment as they needed (osteotomy, external and/or internal fixation systems, etc.) | Biological | Autologuos MSCs transplantation in nonunion defects |
| Transplantation of allogeneic MSCs in nonunion fractureAt surgery, fibrotic tissue is removed from the nonunion sites. MSCs/Col/PRP clots are implanted in the site of nonunion. Patients received conventional orthopedic treatment as they needed (osteotomy, external and/or internal fixation systems, etc.) | Biological | Allogeneic MSCs transplantation in nonunion defects |
Primary outcome
Clinical evaluation
Time frame: Baseline, 1 and 7 days. 1, 2 and 6 months. 1 and 2 years
Time of surgical wound evolution, surgically intervened limb evolution, movility
Bone consolidation
Time frame: Baseline, 1 and 7 days. 1, 2 and 6 months. 1 and 2 years
Time of development changes in bone consolidation by radiological studies
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Background: PubMed 26980620Wittig O, Romano E, Gonzalez C, Diaz-Solano D, Marquez ME, Tovar P, Aoun R, Cardier JE. A method of treatment for nonunion after fractures using mesenchymal stromal cells loaded on collagen microspheres and incorporated into platelet-rich plasma clots. Int Orthop. 2016 May;40(5):1033-8. doi: 10.1007/s00264-016-3130-6. Epub 2016 Mar 16.
- Background: PubMed 29678307Wittig O, Diaz-Solano D, Cardier J. Viability and functionality of mesenchymal stromal cells loaded on collagen microspheres and incorporated into plasma clots for orthopaedic application: Effect of storage conditions. Injury. 2018 Jun;49(6):1052-1057. doi: 10.1016/j.injury.2018.04.005. Epub 2018 Apr 5.
- Background: PubMed 26194170Diaz-Solano D, Wittig O, Mota JD, Cardier JE. Isolation and Characterization of Multipotential Mesenchymal Stromal Cells from Congenital Pseudoarthrosis of the Tibia: Case Report. Anat Rec (Hoboken). 2015 Oct;298(10):1804-14. doi: 10.1002/ar.23198. Epub 2015 Jul 30.
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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.
Jose E Cardier Montalvo, MD, PhD study chair
Instituto Venezolano de Investigaciones Cientificas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Transplantation of autologous MSCs in nonunion fracture and Transplantation of allogeneic MSCs in nonunion fracture in people with Pseudoarthrosis of Bone and Pseudarthrosis, run by Instituto Venezolano de Investigaciones Cientificas at 1 site in Venezuela.
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 9 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 31 Oct 2023. 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 Venezuela. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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?
Clinical evaluation (time frame: Baseline, 1 and 7 days. 1, 2 and 6 months. 1 and 2 years). The study lists 2 primary outcomes in all. 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 NCT06103396, 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 31 Oct 2023.