CLINICAL TRIALS PROFILE FOR TRYPAN BLUE

All Clinical Trials for trypan blue

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT04990128 ↗	Bone Marrow Aspirate Concentrate Versus Triamcinolone Injection For Hip Osteoarthritis	Not yet recruiting	Lisa Dean Moseley Foundation	Phase 3	2022-01-01	This is a single site, randomized single blinded, two arm study researching the effects of bone marrow aspirate concentrate (BMAC) versus Triamcinolone in patients with hip osteoarthritis. The aims and hypothesis are as follows: Specific Aim 1: Evaluate the change in pain and functional scores of a single bone marrow aspirate injection in comparison to triamcinolone in patients with hip osteoarthritis through validated patient reported outcomes scores at baseline to 12 months (6 weeks, 3 months, 6 months, and 12 months). Hypothesis: The investigators hypothesize that triamcinolone and BMAC groups will have pain reduction after each respective intervention. The changes with triamcinolone will be noticeable on the short term. The BMAC changes will take longer to have an effect but will longer duration. The investigators hypothesize that at 6 months and 1 year participants receiving BMAC will have better scores reported on the WOMAC compared to the triamcinolone injection and better than prior to injection. Specific Aim 2: Evaluate the change of bone marrow aspirate injection in comparison to triamcinolone in participant's performance on the 6 minute walk test from baseline to 12 months (6 weeks, 3 months, 6 months, and 12 months). Hypothesis: The investigators hypothesize that there will be higher walking distances on the 6 minute walk test in the participants receiving a BMAC injection in comparison to triamcinolone starting at the 3 months follow-up time. Specific Aim 3: Quantify and correlate cell characterization with patient reported outcomes score. Hypothesis: The investigators hypothesize that there will be better patient reported outcomes in patients who have a higher concentration of mesenchymal stem cells injected. The investigators will enroll 50 patients into each arm. Bone marrow will be aspirated then subsequently concentrated using the Emcyte PureBMC kit. The investigators will test the BMAC viability, rapid sterility, endotoxin, platelet concentration, volume, and total nucleated cell counts prior to injecting. The BMAC will be utilized as a hip injection into the affected hip of the patient. Patients receiving the Triamcinolone will undergo a sham bone needling to simulate the aspiration to keep patients blinded. Both groups will receive their injections under ultrasound guidance.
NCT03692221 ↗	Mesenchymal Stem Cells for Lumbar Degenerative Disc Disease	Not yet recruiting	Salim M Hayek	Early Phase 1	2019-06-01	This study seeks to bridge these technologies and obtain data regarding the safety and efficacy of image guided percutaneous needle injection of expanded autologous bone marrow derived mesenchymal stem cells to symptomatic degenerated intervertebral discs in humans. The primary outcome will be to assess the safety and efficacy and monitor for adverse events.
NCT01903473 ↗	Donor Regulatory T Cells Infusion in Patients With Chronic Graft-versus-host Disease (GVHD)	Recruiting	University Hospital of Liege	Phase 2	2013-07-01	The immune system has offensive and defensive capacities. In bone marrow transplantation, offensive cells in the donor grafts may attack host's organs, leading to a complication known as Graft versus Host Disease (GVDH). At present, patients receive steroid treatment to combat this tricky situation. Nevertheless, some patients do not respond to this therapy. Recently, it has been shown that immune system cells having defensive capacities can help in preventing the occurrence of a GVDH. This study aims to evaluate if these protective cells together with a non-standard immunosuppressor can improve the clinical condition and suppress the activity of the offensive cells in the graft.
NCT01903473 ↗	Donor Regulatory T Cells Infusion in Patients With Chronic Graft-versus-host Disease (GVHD)	Recruiting	University of Liege	Phase 2	2013-07-01	The immune system has offensive and defensive capacities. In bone marrow transplantation, offensive cells in the donor grafts may attack host's organs, leading to a complication known as Graft versus Host Disease (GVDH). At present, patients receive steroid treatment to combat this tricky situation. Nevertheless, some patients do not respond to this therapy. Recently, it has been shown that immune system cells having defensive capacities can help in preventing the occurrence of a GVDH. This study aims to evaluate if these protective cells together with a non-standard immunosuppressor can improve the clinical condition and suppress the activity of the offensive cells in the graft.
NCT00947453 ↗	Sputum Matrix Metalloproteinases (MMP) mRNA and Montelukast	Completed	Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)	Phase 2	2009-07-01	Matrix metalloproteinases (MMPs) are a group of 24 zinc containing enzymes in man. These enzymes were originally described as cleaving extracellular matrix (ECM) substrates with a predominant role in ECM homeostasis, but it is now clear that they have much wider functionality. An imbalance between MMP activity and that of their inhibitors (tissue inhibitors of metalloproteinases, TIMPs) is considered to play a critical role in the synthesis or degradation of the extracellular matrix of the airway architecture which results in fixed airflow obstruction in both asthma and chronic obstructive pulmonary disease (COPD). Using quantitative real time polymerase chain reaction (RT-PCR) the investigators have identified a difference between the level of steady state mRNA for MMP-9, MMP-14 and MMP-2 in 2 patients with asthma compared to 4 healthy controls using our method. However the investigators require further refinement of the process in order to optimise RNA quality and to evaluate the effect of montelukast across the entire family of MMPs and their inhibitors (TIMPs).
NCT00947453 ↗	Sputum Matrix Metalloproteinases (MMP) mRNA and Montelukast	Completed	University of East Anglia	Phase 2	2009-07-01	Matrix metalloproteinases (MMPs) are a group of 24 zinc containing enzymes in man. These enzymes were originally described as cleaving extracellular matrix (ECM) substrates with a predominant role in ECM homeostasis, but it is now clear that they have much wider functionality. An imbalance between MMP activity and that of their inhibitors (tissue inhibitors of metalloproteinases, TIMPs) is considered to play a critical role in the synthesis or degradation of the extracellular matrix of the airway architecture which results in fixed airflow obstruction in both asthma and chronic obstructive pulmonary disease (COPD). Using quantitative real time polymerase chain reaction (RT-PCR) the investigators have identified a difference between the level of steady state mRNA for MMP-9, MMP-14 and MMP-2 in 2 patients with asthma compared to 4 healthy controls using our method. However the investigators require further refinement of the process in order to optimise RNA quality and to evaluate the effect of montelukast across the entire family of MMPs and their inhibitors (TIMPs).

Clinical Trial Conditions for trypan blue

Condition Name

Condition Name for trypan blue
Intervention	Trials
Malignant Peritoneal Effusion	1
Malignant Pleural Effusion	1
Steroid Refractory Graft-Versus-Host Disease	1
Acute Graft-Versus-Host Disease	1

Condition MeSH

Condition MeSH for trypan blue
Intervention	Trials
Graft vs Host Disease	1
Asthma	1
Pleural Effusion, Malignant	1
Pleural Effusion	1

Clinical Trial Locations for trypan blue

Trials by Country

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−

Trials by Country for trypan blue
Location	Trials
United States	2
Belgium	2
China	1
United Kingdom	1

Trials by US State

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−

Trials by US State for trypan blue
Location	Trials
Florida	1
Ohio	1

Clinical Trial Progress for trypan blue

Clinical Trial Phase

Clinical Trial Phase for trypan blue
Clinical Trial Phase	Trials
Phase 3	1
Phase 2	2
Early Phase 1	2

Clinical Trial Status

Clinical Trial Status for trypan blue
Clinical Trial Phase	Trials
Recruiting	2
Not yet recruiting	2
Completed	1

Clinical Trial Sponsors for trypan blue

Sponsor Name

Sponsor Name for trypan blue
Sponsor	Trials
Sheng Hu	1
Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)	1
University of East Anglia	1

Sponsor Type

Sponsor Type for trypan blue
Sponsor	Trials
Other	8
Industry	1

Trypan Blue: Clinical Trials, Market Analysis, and Projections

Introduction to Trypan Blue

Trypan blue, an azo dye with a molecular weight of 960 Da, has been a staple in cell viability measurements for over a century. It is known for its ability to concentrate in membrane-compromised dead or dying cells, while being excluded from live cells with intact membranes[1].

Clinical Applications of Trypan Blue

Cell Viability Measurements

Trypan blue is widely used in biomedical research and clinical settings to assess cell viability. However, its use has been associated with several issues, including the transformation of dead cells into dim and diffuse shapes, which can lead to the overestimation of cell viability, particularly when viability falls below 80%[1].

Ocular Surgery

In the field of ophthalmology, trypan blue has found significant utility. It is used to visualize antimetabolite-soaked sponges during trabeculectomy, helping to estimate the treatment area and identify unintended tissue contact. This application does not alter the cytotoxicity of the antimetabolites and has been shown to be safe and effective in clinical settings[3].

Proliferative Vitreoretinopathy (PVR)

Trypan blue is also a valuable tool in the surgical management of PVR, a complication of retinal detachment surgery. It enhances the visualization and removal of epiretinal membranes (ERMs), reducing the risk of inadvertent retinal damage. The dye creates a clear contrast between the stained ERMs and the underlying retina, facilitating a more complete and safer removal of these membranes[4].

Clinical Trials and Safety

Cell Counting Accuracy

Clinical trials and research have highlighted the importance of accurate cell counting and viability assessment, especially in cellular therapies like CAR-T cell treatments. Trypan blue staining can lead to the undercounting of dead cells and overestimation of viability, which may have significant implications for treatment efficacy and patient safety. Alternative methods, such as fluorescent nuclear staining, are recommended for more accurate viability assessments[1].

Ocular Safety

In ophthalmic surgeries, trypan blue has been evaluated for its biocompatibility and safety. Studies have shown that trypan blue does not affect the cytotoxicity of antimetabolites and does not cause adverse reactions when used in appropriate concentrations. Long-term exposure studies in rabbit models have also confirmed its safety for retinal tissue[4].

Market Analysis and Projections

Current Market

The global market for trypan blue has experienced significant growth in recent years. The European market, for instance, was valued at a substantial amount in 2023 and is projected to grow at a notable CAGR through 2030[2].

Market Drivers

The increasing demand for accurate cell viability measurements in biomedical research and clinical applications, particularly in the burgeoning field of cellular therapies, drives the growth of the trypan blue market. Additionally, its expanding use in ophthalmic surgeries and other medical procedures contributes to its market expansion[5].

Market Challenges

Despite its widespread use, trypan blue faces challenges related to its accuracy in cell viability measurements. The development of alternative staining methods and technologies that offer more precise cell counting and viability assessments could potentially impact the market share of trypan blue[1].

Future Projections

Continued Growth

The trypan blue market is expected to continue its growth trajectory, driven by advancements in biomedical research, the increasing adoption of cellular therapies, and its established role in ophthalmic surgeries. However, the market will need to adapt to emerging technologies and methods that offer improved accuracy and reliability in cell viability assessments[5].

Technological Advancements

The integration of advanced imaging technologies, such as those used in Cellometer instruments, which can clearly image dim and diffuse objects formed after trypan blue staining, will be crucial for maintaining the relevance of trypan blue in the market. These advancements can help mitigate the issues associated with traditional brightfield counting methods[1].

Key Takeaways

• Clinical Applications: Trypan blue is used in cell viability measurements, ocular surgeries, and the management of PVR.
• Accuracy Concerns: It can lead to overestimation of cell viability, particularly below 80% viability.
• Market Growth: The market is driven by demand in biomedical research and ophthalmic surgeries.
• Future Trends: The market will need to adapt to emerging technologies offering improved accuracy in cell viability assessments.

FAQs

What is trypan blue used for in biomedical research?

Trypan blue is used to assess cell viability by staining dead or dying cells while excluding live cells.

How does trypan blue affect cell counting accuracy?

Trypan blue can transform dead cells into dim and diffuse shapes, leading to the overestimation of cell viability, especially when viability is below 80%.

What are the clinical applications of trypan blue in ophthalmology?

Trypan blue is used to visualize antimetabolite-soaked sponges during trabeculectomy and to enhance the visualization and removal of epiretinal membranes in PVR surgeries.

Is trypan blue safe for use in ophthalmic surgeries?

Yes, trypan blue has been shown to be safe and effective in ophthalmic surgeries, with no adverse reactions reported in clinical studies.

What are the market projections for trypan blue?

The trypan blue market is expected to continue growing, driven by its use in biomedical research and ophthalmic surgeries, despite the need to adapt to emerging technologies offering improved accuracy.

Sources

1. Revvity, "Is your Trypan blue rupturing dead or dying immune cells leading to overestimation of cell viability?"
2. Valuates Reports, "Global Trypan Blue Market, Report Size, Worth, Revenue, Growth, Industry"
3. PubMed, "Trypan blue identifies antimetabolite treatment area in trabeculectomy"
4. JAMA Ophthalmology, "Trypan Blue Staining of Epiretinal Membranes in Proliferative Vitreoretinopathy"
5. Market Research Intellect, "Global Trypan Blue Solution Market Size, Scope And Forecast Report"