Clinical Trials
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Phase 2 Study
Stanford University Medical Center
Exploratory Phase 2 Study in Lymphedema of the Lower Limbs Delivered Positive Data for All Endpoints
An investigator-initiated Phase 2 study in non-cancer lymphedema was completed at Stanford University Medical Center. This study explored daily administration of our drug over a 12 month period. The key readouts included:
- Change in limb volume
- Change in skin fold thickness
- Changes in tissue thickness and architecture
- Quality of life
- Bioimpedance
- Frequency of cellulitis
On average patients experienced a change in limb volume of over 1L - which is equivalent to removing two water bottles out of your pockets!
Positive changes to tissue architecture and subcutaneous fat were also observed, and many patients were overjoyed at their response.
Patient Testimonials
“My compression garment became looser”
“When I used to squat, I would tip over, but not anymore. I have a lot more mobility.”
“My lymphedema limbs used to feel heavy, and it would be difficult to get through the day without feeling exhausted, now I feel energized and light all around.”
“I see a dramatic difference in my participation in the trial, my upper legs seem identical.”
“I put on a pair of wedge heels this morning for work, my toes are near similar size to my no lymphedema foot and have a lot more room to move in my joints”
Clinical Data
Our immune modulating drugs have been demonstrated in clinical trials to have the following beneficial effects.
| Therapeutic Effect | Clinical |
|---|---|
| Decreased Limb Volume | ✓ |
| Decreased Skin Thickness | ✓ |
| Reduced Epidermal Alteration | ✓ |
| Improved Subdermal Architecture | ✓ |
| Reduced Adipose Disruption | ✓ |
| Reduced Fibrotic Remodeling | ✓ |
| Reduced Inflammatory Infiltrates | ◆ |
| Improved Quality of Life | ✓ |
◆ Demonstrated in human skin with an immune modulator acting in the same pathway.
Important Note
It is important to note that this investigational therapy has not been approved by the US Food and Drug Administration for the treatment of lymphedema, lipedema, or any other condition. Clinical studies are ongoing, and additional research is needed to fully understand safety, efficacy, and long-term impact.
Preclinical Research
In addition to ongoing clinical studies, supportive preclinical research has been conducted to better understand how modulating inflammation, lymphatic function, adipose tissue remodeling, and fibrosis may influence tissue-level changes.
In established animal models of lymphedema, investigational compounds from Celltaxis have been studied using tissue histology and structural analyses. These preclinical evaluations have demonstrated:
- Reductions in dermal and subcutaneous tissue thickening
- Decreased inflammatory cell infiltration
- Reversal of fibrotic remodeling
- Improvement on Normalization of epidermal tissue structure
- Normalization of tissue architecture
These preclinical findings provide biological support for the mechanisms under investigation and are consistent with areas being evaluated in ongoing human clinical studies. While animal model findings do not necessarily predict clinical outcomes, they help inform study design and deepen understanding of disease biology.
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Preclinical
Tissue Analysis
Additional Studies Ongoing
Exploratory Phase 2 Study in Lymphedema of the Upper Limbs Ongoing
Exploratory Phase 2 Study in Lipedema Enrolling.
Exploratory Phase 2 Upper Limb Extension Study Ongoing