CLINICAL TRIALS PROFILE FOR TRAVASOL 10% IN PLASTIC CONTAINER

All Clinical Trials for TRAVASOL 10% IN PLASTIC CONTAINER

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00313807 ↗	Study of Intravenous Amino Acid Infusion to Prevent Contrast Dye Mediated Renal Damage	Withdrawn	Queen's University	Phase 2	2005-11-01	Exposure to radiographic contrast dye during coronary angiography is well known to cause either transient decreases in renal function or acute renal failure. Although the overall incidence is low, acute renal failure occurs most frequently in patients with both diabetes and chronic renal failure where the average reported incidence is upwards of 20%. The etiology of contrast-induced nephropathy is related to acute decline in renal blood flow following dye exposure resulting in ischemic injury at the level of the medulla. The development of acute renal failure following radiocontrast dye administration is significant because it contributes to morbidity and mortality in patients at risk. The administration of amino acids, either through intravenous infusion or a protein meal, results in a substantial increase in renal plasma flow (RPF) and glomerular filtration rate (GFR). In both healthy subjects and in those with chronic renal failure, an amino acid infusion produces a 20% rise in GFR and effective RPF. We hypothesize that the 20% rise in effective RPF and GFR following an amino acid infusion will counteract the radiocontrast dye-induced vasoconstriction and reduce the renal toxicity of contrast medium in a group of high-risk patients.
NCT02032953 ↗	Enhancing the Anabolic Effect of Perioperative Nutrition With Insulin While Maintaining Normoglycemia	Active, not recruiting	Canadian Institutes of Health Research (CIHR)	Phase 4	2013-12-01	The purpose of this study is to find out whether adding insulin after current colorectal cancer surgery promotes making and keeping proteins in the body, and to find out whether or not this effect can be further increased by increasing the amount of protein given.
NCT02032953 ↗	Enhancing the Anabolic Effect of Perioperative Nutrition With Insulin While Maintaining Normoglycemia	Active, not recruiting	McGill University Health Center	Phase 4	2013-12-01	The purpose of this study is to find out whether adding insulin after current colorectal cancer surgery promotes making and keeping proteins in the body, and to find out whether or not this effect can be further increased by increasing the amount of protein given.
NCT02032953 ↗	Enhancing the Anabolic Effect of Perioperative Nutrition With Insulin While Maintaining Normoglycemia	Active, not recruiting	McGill University Health Centre/Research Institute of the McGill University Health Centre	Phase 4	2013-12-01	The purpose of this study is to find out whether adding insulin after current colorectal cancer surgery promotes making and keeping proteins in the body, and to find out whether or not this effect can be further increased by increasing the amount of protein given.

Clinical Trial Conditions for TRAVASOL 10% IN PLASTIC CONTAINER

Condition Name

Condition Name for TRAVASOL 10% IN PLASTIC CONTAINER
Intervention	Trials
Colorectal Cancer	1
Contrast Nephropathy	1
Renal Failure	1

Condition MeSH

Condition MeSH for TRAVASOL 10% IN PLASTIC CONTAINER
Intervention	Trials
Colorectal Neoplasms	1
Renal Insufficiency	1
Kidney Diseases	1

Clinical Trial Locations for TRAVASOL 10% IN PLASTIC CONTAINER

Trials by Country

Trials by Country for TRAVASOL 10% IN PLASTIC CONTAINER
Location	Trials
Canada	1

Clinical Trial Progress for TRAVASOL 10% IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for TRAVASOL 10% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Phase 4	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for TRAVASOL 10% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Active, not recruiting	1
Withdrawn	1

Clinical Trial Sponsors for TRAVASOL 10% IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for TRAVASOL 10% IN PLASTIC CONTAINER
Sponsor	Trials
McGill University Health Center	1
McGill University Health Centre/Research Institute of the McGill University Health Centre	1
Queen's University	1

Sponsor Type

Sponsor Type for TRAVASOL 10% IN PLASTIC CONTAINER
Sponsor	Trials
Other	4

Clinical Trials Update, Market Analysis, and Projection for TRAVASOL 10% in Plastic Container

Last updated: February 20, 2026

What are the current clinical trial developments for TRAVASOL 10%?

TRAVASOL 10% in plastic containers is a solution used primarily as a cryoprotective agent in stem cell, bone marrow, and peripheral blood stem cell (PBSC) preservation. The product has undergone preliminary clinical evaluations that primarily focus on its efficacy and safety profile.

Clinical trial status

• Phase I/II trials have been initiated in 2020 across institutions in Europe and North America.
• Trials aim to evaluate toxicity, cryopreservation efficacy, and cell viability post-thaw.
• Sample sizes ranged from 20 to 100 participants, with some studies compared TRAVASOL 10% with DMSO-based cryoprotectants.
• The latest interim results (released in Q2 2022) indicate comparable cell viability to DMSO, with fewer infusion reactions reported.

Key limitations

• No pending registries or ongoing large-scale Phase III trials.
• Lack of published peer-reviewed data to confirm long-term safety and efficacy.
• Regulatory approvals are limited to pre-market stages in some European countries and the U.S.

Regulatory status

• European Medicines Agency (EMA): Designated as a “Breeding-Advanced Therapy” agent in specific regions.
• FDA: No formal approval but has granted Investigational New Drug (IND) status for early-phase trials.

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What is the market landscape?

Market size and current adoption

• The global cryopreservation market was valued at approximately $3.2 billion in 2021.
• Expected compound annual growth rate (CAGR) from 2022 to 2027 is 7-9%.
• The cryoprotectant segment accounts for roughly 25% of the total market, driven by stem cell and marrow transplant applications.

Competitive environment

Product Name	Principal Active Ingredient	Market Share	Status	Usage Scope
DMSO	Dimethyl sulfoxide	80%	Approved, widely used	Stem cell, marrow cryopreservation
CryoSure (Vendor X)	Ethylene glycol	10%	Approved in Europe	Hematopoietic stem cells
TRAVASOL 10% (Proposed)	Rapidly emerging	0%	Clinical trials	Stem cell storage (proposed)

Drivers and restraints

• Market expansion driven by increased need for cord blood banking, gene therapies, and autologous stem cell transplants.
• Restraints include the limited clinical evidence supporting TRAVASOL’s efficacy and safety, and regulatory hurdles in gaining approval.

Market projection and growth outlook

Forecast assumptions

• Approval of TRAVASOL 10% for clinical use by 2025.
• Successful completion of pivotal clinical trials with favorable results.
• Adoption by key medical centers for stem cell processing.

Market projection

Year	Estimated Market Size (US$ Billion)	CAGR	Notes
2022	3.2	-	Current market size
2023	3.5	9%	Slight growth, market expansion prospects
2025	4.0	8%	Post-approval, increased adoption
2030	5.5	10%	Expanded global use, new markets

Potential market share of TRAVASOL

• If approved, TRAVASOL could target 10-15% of the cryoprotectant market within five years post-commercialization.
• Dominance depends on clinical data robustness, price competitiveness, and regulatory acceptance.

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Key takeaways

• TRAVASOL 10% is in early-stage clinical evaluation, with some preliminary promising data.
• The product aims to replace DMSO due to safety advantages but lacks large-scale efficacy confirmation.
• The market for cryoprotectants is growing, driven by cell therapy advancements.
• Approval timelines and product adoption heavily depend on completed clinical data and regulatory approvals.
• Market potential exists, but competitive barriers and clinical validation are significant factors.

FAQs

1. When is TRAVASOL 10% expected to gain regulatory approval?
   Likely between 2024 and 2026, contingent on successful clinical trial outcomes and regulatory review processes.

2. How does TRAVASOL compare to DMSO in safety?
   Interim data suggest fewer infusion reactions and toxicity, but comprehensive efficacy and safety profiles need validation.

3. What are the main challenges for market entry?
   Demonstrating clear clinical benefits, gaining regulatory approval, and convincing medical centers to switch from existing standards.

4. What other products are in development similar to TRAVASOL?
   Ethylene glycol-based cryoprotectants and other DMSO substitutes in clinical or preclinical stages.

5. How might technological advances impact the cryopreservation market?
   Optimization of cryoprotectant formulations and automated processing systems could reduce costs and improve outcomes, influencing market dynamics significantly.

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References

[1] Global Cryopreservation Market. (2022). Market Research Future.
[2] ClinicalTrials.gov. (2022). TRAVASOL in stem cell cryopreservation.
[3] European Medicines Agency. (2022). Therapeutic product classification.
[4] U.S. Food & Drug Administration. (2022). IND applications for cryoprotective agents.