Musculoskeletal InjuryPhase 1/2NCT06074783
A Study of Human Allogeneic Bone-marrow Derived Mesenchymal Stromal Cell Product (StromaForte) in Patients With Musculoskeletal Injuries and/or Degeneration
A Phase 1/2 study testing Human Allogeneic Bone-Marrow (BM) -Derived Mesenchymal Stromal Cells (MSCs) Product (StromaForte) in people with Musculoskeletal Injury, run by Cellcolabs Clinical LTD. at 1 site in The Bahamas.
Trial summary
The goal of this ongoing open-label, single-arm, phase I/IIa study in patients is designed to assess the safety of human allogeneic BM-derived MSCs product StromaForte for musculoskeletal injury or/and degeneration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Musculoskeletal Injury
- What is being tested?
- Human Allogeneic Bone-Marrow (BM) -Derived Mesenchymal Stromal Cells (MSCs) Product (StromaForte)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteThe Bahamas
- Study dates
- 20 Oct 2023to 19 Oct 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide written informed consent and comply with all procedures required by the protocol.
- Aged ≥ 18 years at the time of signing the informed consent form and has any diagnosed musculoskeletal injury and/or degenerative conditions.
Who cannot join
- Unwilling or unable to perform any of the assessments required by the protocol.
- Have an injury that is expected to selfheal within 14 days without remaining sequel.
- Have an injury for which there is solid scientific evidence that the study compound will have no effect.
- Have traumatic head injury or skull, teeth or jaw injury as diagnosis for inclusion in trial.
- Have an injury that require an orthopaedic surgery that has not been addressed by local/home surgeon.
- Have end stage liver or renal disease.
Show all 19Show fewer
- Have a clinical history of malignancy within 2.5 years (i.e., patients with prior malignancy must be cancer free for 2.5 years) except curatively treated basal cell carcinoma, melanoma in situ, or cervical carcinoma.
- Have any condition that limits lifespan to < 1 year according to the Principal Investigator's discretion.
- Hepatitis B virus positive
- Viraemic Hepatitis C virus, HIV-1/2 or syphilis positive
- Have unstable angina pectoris, uncontrolled or severe peripheral artery disease within the previous 2 months.
- Have congestive heart failure defined by New York Heart Association (NYHA) Class IV, or an ejection fraction of <25%.
- Uncontrolled hypertension (resting systolic blood pressure >220 mm Hg or diastolic blood pressure of > 150 mm Hg at screening) .
- Have coronary artery bypass surgery, angioplasty, peripheral vascular disease revascularization, or a myocardial infarction within the previous month.
- Have acute exacerbation of chronic obstructive lung disease stage III or IV (Gold classification), Have cognitive or language barriers that prohibit obtaining informed consent or any study elements.
- Severe acute infection at time of screening and treatment with study drug
- Pregnant or Breastfeeding
- Currently participating (or participated within the previous 30 days of consent) in an investigational therapeutic or device trial.
- Have a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the patient's participation for the full duration of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rikin Patel, DO contact
The Bahamas1 site, 1 recruiting
- Recruiting
Live Well
Nassau, The Bahamas
Darius Bain, MD, info@livewellbahamas.com
About this study
Official title: A Patient Sponsored Ongoing Open-label Single-arm, Safety and Efficacy, Phase I/IIb Study of Cellcolabs´ Human Allogeneic Bone-marrow Derived Mesenchymal Stromal Cell Product (StromaForte) in Patients With Musculoskeletal Injuries and/or Degeneration
The goal of this ongoing open-label, single-arm, phase I/IIa study in patients is designed to assess the safety of human allogeneic BM-derived MSCs product StromaForte for musculoskeletal injury or/and degeneration. Any male or female with any musculoskeletal injury and/or degeneration above 18 years will be enrolledThe main questions it aims to answer are:
To assess the safety after 28±10, 84±10, 168±10 and 349±10 days of injection by reporting the number of adverse events or severe adverse event assessed by Common Terminology Criteria
Read more
Change from baseline in subjective pain assessment in each injured and/or degenerated area (if multiple injury is reported, each area to be followed up separately)
Eligible patients will receive 50 x 106 allogeneic bone marrow (BM)-derived MSC formulated in 4 ml infusion solution of sodium chloride supplemented with human serum albumin to be given locally under ultrasound guidance along with or without 100 x 106 allogeneic BM-derived MSCs formulated in sodium chloride supplemented with human serum albumin to be given via slow intravenous infusion in approximately 30 min. Systemic treatment alone is used when local injection at site of injury is not feasible. Additional dose can be administered.
Read the detailed description
Musculoskeletal disorders (MSDs) and injuries represent a significant global health concern, constituting the primary cause of disability on a global scale. With a high prevalence spanning various stages of life, from childhood to old age, MSDs exert a substantial burden on individuals and society alike. This burden is particularly amplified in the context of an aging population and the prevalence of multi-morbidity. Chronic illnesses and health conditions not only lead to reduced quality of life but also contribute to a substantial financial burden on societies due to increased healthcare costs and lost productivity. In this context, the inability to work and early retirement are often driven by these health issues, forming a critical dimension of the disease burden.
Regular physical exercise is a crucial factor in promoting longevity and overall well-being. Unfortunately, MSDs can significantly impede individuals' ability to engage in exercise and pursue the hobbies and activities that bring them happiness. These disorders often limit mobility, cause pain, and hinder their capacity to lead an active lifestyle.
Addressing and mitigating these MSDs becomes pivotal in restoring individuals' functional capabilities and quality of life. By effectively managing these conditions, we can empower patients to maintain regular exercise routines that contribute to their physical health, mental well-being, and happiness. Encouraging patients to stay active and engaged not only enhances their own lives but also contributes to a healthier and more vibrant society. Ultimately, the ability to exercise and partake in fulfilling activities stands as a cornerstone for longevity, fostering a balanced and fulfilling life journey.
The spectrum of MSDs encompasses a diverse range of conditions, impacting vital musculoskeletal structures such as bones, joints, muscles, tendons, and ligaments [3]. These disorders can originate from a myriad of factors, including traumatic incidents, degenerative processes, autoimmune responses, and genetic predispositions. The consequence is often chronic pain, compromised mobility, diminished physical function, and a diminished quality of life. Among the array of MSDs, the pervasive influence of osteoarthritis is particularly noteworthy, contributing significantly to the global burden of disease.
Addressing musculoskeletal injuries and degeneration presents an urgent imperative due to the widespread prevalence and devastating impact of these conditions. An emerging avenue of exploration lies in the utilization of mesenchymal stem cells (MSCs), which hold immense potential for revolutionizing regenerative medicine. MSCs, found within diverse tissues including bone marrow and adipose tissue, possess the remarkable ability to differentiate into various cell lineages such as osteocytes, chondrocytes, and myocytes. This intrinsic versatility positions them as key players in tissue regeneration and repair.
The rationale for delving into MSC-based therapies rests upon their extraordinary regenerative potential. When applied to the site of injury or degeneration, MSCs can contribute to the reconstitution of damaged tissues, promoting structural and functional recovery. Moreover, MSCs wield immunomodulatory properties, a crucial attribute given the intricate role of the immune response in MSD progression. By modulating immune cell activity, MSCs can foster an anti-inflammatory environment, counteracting the detrimental effects of chronic inflammation observed in numerous MSDs.
In the larger context, the exploration of mesenchymal stem cells as a therapeutic avenue for musculoskeletal injuries and/or degeneration signifies a pioneering leap within the realm of regenerative medicine. The aspiration to alleviate pain, restore mobility, and enhance functionality holds the promise of ameliorating the extensive repercussions endured by individuals grappling with musculoskeletal disorders. MSCs therapy holds the potential to not only alleviate symptoms and improve the quality of life for individuals with musculoskeletal conditions but also to reduce the economic strain caused by decreased workability and early retirement. By promoting tissue repair, reducing inflammation, and enhancing overall musculoskeletal health, MSCs treatment can contribute to extending a person's productive years and lessening the burden on both individuals and society.
Learning more about stem cell applications for a diverse set of musculoskeletal disorders will allow for more specific studies to be designed and more niched groups of study participants to be targeted. A particularly interesting field of indications and study participants resides in the realm of elite sports. Elite athletes, sports teams, organizations, and federations invest huge resources to push the quality in sports to unprecedented levels. In that quest, sports injuries pose a devastating blocker for the athletes and the organizations as it can hamper an individual's career and the success of a team. With this study, one of our aspirations for the future is to partner up with relevant sports associations, teams, and institutions and leverage sought insights to design a study aimed at offering elite athletes the highest quality treatments to help them stay healthy, and in the unlucky event of an injury, return to their sport in the shortest time possible.
- Conditions
- Musculoskeletal Injury
- Being tested
- Human Allogeneic Bone-Marrow (BM) -Derived Mesenchymal Stromal Cells (MSCs) Product (StromaForte)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Allogeneic Bone-Marrow (BM) -Derived Mesenchymal Stromal Cells (MSCs) Product (StromaForte)Biological
50 x 106 allogeneic BM-derived MSCs formulated in 4 ml infusion solution of sodium chloride supplemented with human serum albumin to be given locally under state of the art way of application that is ultrasound guidance which will ensure precise delivery of the BM derived MSCs at the site of injury or degeneration along with or without 100 x 106 allogeneic BM-derived MSCs formulated in sodium chloride supplemented with human serum albumin to be given via slow intravenous infusion in approximately 30 min. Systemic treatment alone is used when local injection at site of injury or degeneration is not feasible.
| Study group | Role | What they receive |
|---|---|---|
| MSC Intervention Group | Experimental | Participants will be enrolled into one of four subgroups listed below Firm connective tissue injury (Cartilage, bone, disc, and meniscus) Firm connective tissue degeneration (Cartilage, bone, disc, and meniscus) Soft connective tissue injury (Ligament, tendons, and muscles) Soft connective tissue degeneration (Ligament, tendons, and muscles)
Treatment: Eligible patients will receive 50 x 106 allogeneic bone marrow (BM)-derived MSC formulated in 4 ml infusion solution of sodium chloride supplemented with human serum albumin to be given locally under ultrasound guidance along with or without 100 x 106 allogeneic BM-derived MSCs formulated in sodium chloride supplemented with human serum albumin to be given via slow intravenous infusion in approximately 30 min. Systemic treatment alone is used when local injection at site of injury is not feasible. Additional dose can be administered. Minimum interval between two local doses is 2 months and systemic doses is 3 months. Receives: Biological: Human Allogeneic Bone-Marrow (BM) -Derived Mesenchymal Stromal Cells (MSCs) Product (StromaForte) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety of human allogenic BM derived MSCs in musculoskeletal injuries and/or degeneration for all patients either face to face or remotely.
To assess the safety after 28±10, 84±10, 168±10 and 349±10 days of injection by reporting the number of adverse events or severe adverse event assessed by Common Terminology Criteria For Adverse Events (CTCAE) which is the Incidence of any treatment-emergent serious adverse events (TE-SAEs), defined as the composite of death, non-fatal pulmonary embolism, stroke, hospitalization for worsening dyspnea and clinically significant laboratory test abnormalities determined per the Investigator's judgment for all patients either face to face or remotely.
Measured: From baseline to 1 year
Secondary outcomes (5)
To evaluate the effect of MSC administration in reported resting pain and pain in movement/loading/weight bearing in each injured and/or degenerated area
To evaluate the effect of MSC administration in reported resting pain and pain in movement/loading/weight bearing in each injured and/or degenerated area (if multiple injuries is reported, each area to be followed up separately) from baseline to 28±10, 84±10, 168±10 and 349±10 days for all patients either face to face or remotely.
Measured: From baseline to 1 year
Change in Health-related quality of life according to Short-Form 36
Change in Health-related quality of life according to Short-Form 36 at 28±10, 84±10, 168±10 and 349±10 days post-injection for all patients either face to face or remotely. SF-36 scores range from 0 (worst) to 100 (best) (5).
Measured: From baseline to 1 year
Change in Health-related quality of life according to Patient Global Impression of Change
Change in Health-related quality of life according to Patient Global Impression of Change at 28±10, 84±10, 168±10 and 349±10 days post-injection for all patients either face to face or remotely. The PGIC scale goes from 1 - 7 with 1 being the best positive outcome and 7 the most negative outcome.
Measured: From baseline to 1 year
Change in pain assessment
Change from baseline in subjective pain assessment. Both resting pain and pain in movement/loading/weight bearing will be assessed according to the VRS questionnaire in pre-existing degenerative disorders, distinct from the condition being treated from the baseline to 28±10, 84±10, 168±10 and 349±10 days for all patients either face to face or remotely. The VRS score is measured 0 - 3 with 0 being no pain and 3 being the maximal pain.
Measured: From baseline to 1 year
Changes in pain between different treatment subgroups
Difference in changes from baseline in pain between subgroups of subjects receiving distinct number of doses at different time intervals
Measured: From baseline to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start20 Oct 2023
- Primary completion19 Oct 2027 (estimated)
- Study completion19 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal InjuryStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cellcolabs Clinical LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06074783
- Sponsor's protocol ID
- 2023-002-BHS
- Status last verified
- Apr 2024
- First submitted
- 4 Oct 2023
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Patient Sponsored Ongoing Open-label Single-arm, Safety and Efficacy, Phase I/IIb Study of Cellcolabs´ Human Allogeneic Bone-marrow Derived Mesenchymal Stromal Cell Product (StromaForte) in Patients With Musculoskeletal Injuries and/or Degeneration
- ClinicalTrials.gov ID
- NCT06074783
- Acronym / sponsor ID
- 2023-002-BHS
- Conditions
- Musculoskeletal Injury
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cellcolabs Clinical LTD.Industry (pharma, biotech, devices)
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 19 Oct 2027 (estimated)
- Study completion
- 19 Oct 2028 (estimated)
- First posted
- 10 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 ongoing open-label, single-arm, phase I/IIa study in patients is designed to assess the safety of human allogeneic BM-derived MSCs product StromaForte for musculoskeletal injury or/and degeneration. Any male or female with any musculoskeletal injury and/or degeneration above 18 years will be enrolledThe main questions it aims to answer are:
To assess the safety after 28±10, 84±10, 168±10 and 349±10 days of injection by reporting the number of adverse events or severe adverse event assessed by Common Terminology Criteria
Change from baseline in subjective pain assessment in each injured and/or degenerated area (if multiple injury is reported, each area to be followed up separately)
Eligible patients will receive 50 x 106 allogeneic bone marrow (BM)-derived MSC formulated in 4 ml infusion solution of sodium chloride supplemented with human serum albumin to be given locally under ultrasound guidance along with or without 100 x 106 allogeneic BM-derived MSCs formulated in sodium chloride supplemented with human serum albumin to be given via slow intravenous infusion in approximately 30 min. Systemic treatment alone is used when local injection at site of injury is not feasible. Additional dose can be administered.
Detailed description
Musculoskeletal disorders (MSDs) and injuries represent a significant global health concern, constituting the primary cause of disability on a global scale. With a high prevalence spanning various stages of life, from childhood to old age, MSDs exert a substantial burden on individuals and society alike. This burden is particularly amplified in the context of an aging population and the prevalence of multi-morbidity. Chronic illnesses and health conditions not only lead to reduced quality of life but also contribute to a substantial financial burden on societies due to increased healthcare costs and lost productivity. In this context, the inability to work and early retirement are often driven by these health issues, forming a critical dimension of the disease burden.
Regular physical exercise is a crucial factor in promoting longevity and overall well-being. Unfortunately, MSDs can significantly impede individuals' ability to engage in exercise and pursue the hobbies and activities that bring them happiness. These disorders often limit mobility, cause pain, and hinder their capacity to lead an active lifestyle.
Addressing and mitigating these MSDs becomes pivotal in restoring individuals' functional capabilities and quality of life. By effectively managing these conditions, we can empower patients to maintain regular exercise routines that contribute to their physical health, mental well-being, and happiness. Encouraging patients to stay active and engaged not only enhances their own lives but also contributes to a healthier and more vibrant society. Ultimately, the ability to exercise and partake in fulfilling activities stands as a cornerstone for longevity, fostering a balanced and fulfilling life journey.
The spectrum of MSDs encompasses a diverse range of conditions, impacting vital musculoskeletal structures such as bones, joints, muscles, tendons, and ligaments [3]. These disorders can originate from a myriad of factors, including traumatic incidents, degenerative processes, autoimmune responses, and genetic predispositions. The consequence is often chronic pain, compromised mobility, diminished physical function, and a diminished quality of life. Among the array of MSDs, the pervasive influence of osteoarthritis is particularly noteworthy, contributing significantly to the global burden of disease.
Addressing musculoskeletal injuries and degeneration presents an urgent imperative due to the widespread prevalence and devastating impact of these conditions. An emerging avenue of exploration lies in the utilization of mesenchymal stem cells (MSCs), which hold immense potential for revolutionizing regenerative medicine. MSCs, found within diverse tissues including bone marrow and adipose tissue, possess the remarkable ability to differentiate into various cell lineages such as osteocytes, chondrocytes, and myocytes. This intrinsic versatility positions them as key players in tissue regeneration and repair.
The rationale for delving into MSC-based therapies rests upon their extraordinary regenerative potential. When applied to the site of injury or degeneration, MSCs can contribute to the reconstitution of damaged tissues, promoting structural and functional recovery. Moreover, MSCs wield immunomodulatory properties, a crucial attribute given the intricate role of the immune response in MSD progression. By modulating immune cell activity, MSCs can foster an anti-inflammatory environment, counteracting the detrimental effects of chronic inflammation observed in numerous MSDs.
In the larger context, the exploration of mesenchymal stem cells as a therapeutic avenue for musculoskeletal injuries and/or degeneration signifies a pioneering leap within the realm of regenerative medicine. The aspiration to alleviate pain, restore mobility, and enhance functionality holds the promise of ameliorating the extensive repercussions endured by individuals grappling with musculoskeletal disorders. MSCs therapy holds the potential to not only alleviate symptoms and improve the quality of life for individuals with musculoskeletal conditions but also to reduce the economic strain caused by decreased workability and early retirement. By promoting tissue repair, reducing inflammation, and enhancing overall musculoskeletal health, MSCs treatment can contribute to extending a person's productive years and lessening the burden on both individuals and society.
Learning more about stem cell applications for a diverse set of musculoskeletal disorders will allow for more specific studies to be designed and more niched groups of study participants to be targeted. A particularly interesting field of indications and study participants resides in the realm of elite sports. Elite athletes, sports teams, organizations, and federations invest huge resources to push the quality in sports to unprecedented levels. In that quest, sports injuries pose a devastating blocker for the athletes and the organizations as it can hamper an individual's career and the success of a team. With this study, one of our aspirations for the future is to partner up with relevant sports associations, teams, and institutions and leverage sought insights to design a study aimed at offering elite athletes the highest quality treatments to help them stay healthy, and in the unlucky event of an injury, return to their sport in the shortest time possible.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MSC Intervention Group | Experimental | Biological: Human Allogeneic Bone-Marrow (BM) -Derived Mesenchymal Stromal Cells (MSCs) Product (StromaForte)Participants will be enrolled into one of four subgroups listed below Firm connective tissue injury (Cartilage, bone, disc, and meniscus) Firm connective tissue degeneration (Cartilage, bone, disc, and meniscus) Soft connective tissue injury (Ligament, tendons, and muscles) Soft connective tissue degeneration (Ligament, tendons, and muscles) Treatment: Eligible patients will receive 50 x 106 allogeneic bone marrow (BM)-derived MSC formulated in 4 ml infusion solution of sodium chloride supplemented with human serum albumin to be given locally under ultrasound guidance along with or without 100 x 106 allogeneic BM-derived MSCs formulated in sodium chloride supplemented with human serum albumin to be given via slow intravenous infusion in approximately 30 min. Systemic treatment alone is used when local injection at site of injury is not feasible. Additional dose can be administered. Minimum interval between two local doses is 2 months and systemic doses is 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Willing and able to provide written informed consent and comply with all procedures required by the protocol.
- Aged ≥ 18 years at the time of signing the informed consent form and has any diagnosed musculoskeletal injury and/or degenerative conditions.
Key exclusion criteria (19 listed)
- Unwilling or unable to perform any of the assessments required by the protocol.
- Have an injury that is expected to selfheal within 14 days without remaining sequel.
- Have an injury for which there is solid scientific evidence that the study compound will have no effect.
- Have traumatic head injury or skull, teeth or jaw injury as diagnosis for inclusion in trial.
- Have an injury that require an orthopaedic surgery that has not been addressed by local/home surgeon.
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 |
|---|---|---|
| Human Allogeneic Bone-Marrow (BM) -Derived Mesenchymal Stromal Cells (MSCs) Product (StromaForte)50 x 106 allogeneic BM-derived MSCs formulated in 4 ml infusion solution of sodium chloride supplemented with human serum albumin to be given locally under state of the art way of application that is ultrasound guidance which will ensure precise delivery of the BM derived MSCs at the site of injury or degeneration along with or without 100 x 106 allogeneic BM-derived MSCs formulated in sodium chloride supplemented with human serum albumin to be given via slow intravenous infusion in approximately 30 min. Systemic treatment alone is used when local injection at site of injury or degeneration is not feasible. | Biological | MSC Intervention Group |
Primary outcome
To evaluate the safety of human allogenic BM derived MSCs in musculoskeletal injuries and/or degeneration for all patients either face to face or remotely.
Time frame: From baseline to 1 year
To assess the safety after 28±10, 84±10, 168±10 and 349±10 days of injection by reporting the number of adverse events or severe adverse event assessed by Common Terminology Criteria For Adverse Events (CTCAE) which is the Incidence of any treatment-emergent serious adverse events (TE-SAEs), defined as the composite of death, non-fatal pulmonary embolism, stroke, hospitalization for worsening dyspnea and clinically significant laboratory test abnormalities determined per the Investigator's judgment for all patients either face to face or remotely.
5 secondary outcomes
To evaluate the effect of MSC administration in reported resting pain and pain in movement/loading/weight bearing in each injured and/or degenerated area
Time frame: From baseline to 1 year
Change in Health-related quality of life according to Short-Form 36
Time frame: From baseline to 1 year
Change in Health-related quality of life according to Patient Global Impression of Change
Time frame: From baseline to 1 year
Change in pain assessment
Time frame: From baseline to 1 year
Changes in pain between different treatment subgroups
Time frame: From baseline to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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.
Rikin Patel, DO contact
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 Human Allogeneic Bone-Marrow (BM) -Derived Mesenchymal Stromal Cells (MSCs) Product (StromaForte) in people with Musculoskeletal Injury, run by Cellcolabs Clinical LTD. at 1 site in The Bahamas.
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 2 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 19 Apr 2024. 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 The Bahamas. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rikin Patel, DO (+1 (908) 864 2991), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety of human allogenic BM derived MSCs in musculoskeletal injuries and/or degeneration for all patients either face to face or remotely. (time frame: From baseline to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Apr 2024.