Trafermin
Also known as: Basic Fibroblast Growth Factor, bFGF, FGF-2, FGF‑2, Fiblast, Fiblast Spray, Recombinant Human bFGF, Trafermin
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Summary
Trafermin is a recombinant human basic fibroblast growth factor (bFGF‑2) marketed as a prescription medication. It is applied by injection (intravenous, subcutaneous, intracordal) or topical spray and has been investigated for promoting tissue repair in settings such as postoperative fistulas, periodontal bone regeneration, voice cord lesions, and acute ischemic stroke. The product is approved in Japan for certain wound‑healing indications, while other uses remain experimental.
Mechanism of Action
Trafermin supplies exogenous bFGF‑2, which binds to fibroblast growth factor receptors on endothelial cells, fibroblasts, osteoblasts and neural cells. Receptor activation triggers downstream MAPK/ERK and PI3K‑Akt pathways, stimulating cell proliferation, angiogenesis, extracellular‑matrix production and tissue remodeling. In experimental stroke models the growth factor reduces infarct size and supports synapse formation; in bone and periodontal tissues it promotes osteogenic differentiation and new bone fill; in mucosal wounds it accelerates epithelial closure.
What the Research Shows
Case reports have described successful closure of intractable pancreatic (50 µg/day via drainage tube) and duodenal fistulas after gastrectomy, with fistulas sealing within 3–4 weeks. A double‑blind, placebo‑controlled stroke trial (286 patients) used a 24‑hour IV infusion of 5 mg or 10 mg Trafermin; the 5‑mg arm showed a non‑significant trend toward better functional outcome and was safe, though the study stopped early for futility. A retrospective series of 40 patients receiving intracordal injections showed dose‑dependent but physiologically minor changes in serum bFGF, supporting local safety. Two phase‑III periodontal trials (total >600 patients) demonstrated significantly greater bone fill at 36 weeks versus placebo and non‑inferiority/superiority versus enamel matrix derivative, with no safety signals. A 1999 review noted ongoing neuroprotective investigations, but clinical benefit remains unproven.
Reported Benefits
Evidence from controlled phase‑III trials indicates that Trafermin markedly enhances alveolar bone regeneration in intrabony periodontal defects, outperforming placebo and matching or exceeding enamel matrix derivative. Small case series suggest it can accelerate closure of persistent postoperative pancreatic and duodenal fistulas when delivered directly to the wound site. In acute stroke, a modest functional trend was observed at a 5 mg dose, and intracordal administration appears to improve voice outcomes without notable systemic effects. Overall, the strongest data support periodontal bone regeneration.
Limitations of the Evidence
Fistula closure data derive from single‑patient case reports, limiting generalizability. The stroke trial was halted early, enrolled fewer participants than planned, and did not achieve statistical significance; thus efficacy remains uncertain. Intracordal findings are retrospective and lack a control group. Long‑term safety beyond the trial periods has not been fully characterized, and most studies are confined to Japanese populations, restricting broader applicability. Additional randomized, blinded trials are needed to confirm benefits in fistula management, neuroprotection, and other off‑label uses.
Safety Considerations
Trafermin was generally well tolerated in periodontal and fistula case reports, with no serious adverse events reported. In the stroke infusion study, participants experienced transient leukocytosis and modest reductions in systolic blood pressure (average 19–22 mm Hg). Intracordal injections showed negligible systemic exposure and no safety concerns. Overall, the safety profile appears favorable for local applications, but clinicians should monitor blood pressure and white‑cell counts during systemic IV infusion and remain vigilant for hypersensitivity reactions.
How It Is Administered
Trafermin can be administered intravenously as a 24‑hour infusion (stroke studies), subcutaneously or topically for wound healing, and directly into tissue defects (e.g., intracordal injection for vocal cord lesions, injection through drainage tubes for pancreatic or duodenal fistulas, and application to periodontal defects during flap surgery). Formulations include a sterile solution for injection and a spray for topical use.
Routes of Administration
Goals & Uses
- Pressure ulcer / skin ulcer healingWound HealingHigh
- Burn wound healingWound HealingModerate
- Angiogenesis promotion in ischemic tissueCardiovascular / IschemiaLow
- Accelerate wound healingWound CareModerate
- Periodontal tissue regenerationDentistry / RegenerationModerate
- Diabetic foot ulcer treatmentWound HealingModerate
- Promote granulation tissue formationTissue RegenerationModerate
Contraindications
- PregnancyPopulationModeratePotential fetal risk or insufficient safety data
- Hypersensitivity to trafermin or excipientsAllergyHigh
- Known malignancy or tumor at wound siteOncologyHigh
- Known hypersensitivity to recombinant bFGFAllergyHigh
- Active malignant neoplasmOncologyHigh
Adverse Effects
- Hypersensitivity / allergic reactionImmunologicalRare
- Contact dermatitisDermatologicalUncommon
- Wound exudate increaseLocal ReactionCommon
- Local erythemaDermatologicCommon
- Application site erythema / irritationLocal ReactionCommon
- FeverSystemicUncommonElevated body temperature
- Hypersensitivity systemic reactionSystemicRare
Drug Interactions
- HeparinLow
- Corticosteroids (topical)Low
- Bevacizumab (anti‑VEGF)Moderate
Population Constraints
- Pediatric patientsAgeRelative
- Patients with active cancerOncologicalAbsolute
- Pediatric patients (<12 y)AgeRelative
- Elderly patients (>75 y)AgeRelative
- Elderly patients with multiple comorbiditiesAge / ComorbidityRelative
Regulatory Status
- European UnionUnapprovedNo EMA approval; only clinical research.
- JPApprovedApproved: skin ulcer, chronic woundMarketed as Fiblast spray.
- United StatesUnapprovedInvestigational; not FDA‑approved.
- United KingdomUnapprovedNot approved by the MHRA. No marketing authorization in the UK.
Approved in Japan (Ministry of Health, Labour and Welfare) for skin ulcer therapy; not approved in the US or EU.
Evidence & Sources
- Journal ArticleModerateKasuga M, et al.2011-01-01T00:00:00.000000Z
- Journal ArticleModerateBogousslavsky J, et al.2002-01-01T00:00:00.000000Z
- Journal ArticleModerateDávalos A1999-01-01T00:00:00.000000Z
- Journal ArticleLowHasegawa T, et al.2023-01-01T00:00:00.000000Z
- Journal ArticleModerateKitamura M, et al.2016-01-01T00:00:00.000000Z
- Journal ArticleModerateTakemoto K, et al.2012-01-01T00:00:00.000000Z
Frequently Asked Questions
What conditions has Trafermin been formally approved to treat?
Trafermin is approved in Japan as a prescription product for wound‑healing applications, such as promoting tissue repair after surgery. Uses in periodontal regeneration, acute stroke, or vocal‑cord therapy are still investigational and not part of the approved label.
How is Trafermin delivered for periodontal bone regeneration?
During periodontal surgery, a 0.3 % rhFGF‑2 solution is applied to the intrabony defect after flap elevation. The drug remains in the site as a gel, allowing local release of bFGF to stimulate bone fill over several months.
Is Trafermin safe for systemic use in stroke patients?
In a phase II/III trial, a 24‑hour IV infusion was well tolerated, but patients showed mild leukocytosis and a drop in systolic blood pressure. No serious safety signals emerged, yet efficacy was not demonstrated, and further studies are required.
Can Trafermin be used to treat persistent postoperative fistulas?
Small case reports describe successful closure of pancreatic and duodenal fistulas using 50 µg/day injections directly into the fistula tract via a drainage tube. While promising, evidence is limited to single patients, and larger studies are needed before routine adoption.
What is Trafermin?
Trafermin is a recombinant human basic fibroblast growth factor (bFGF‑2) marketed as a prescription medication. It is applied by injection (intravenous, subcutaneous, intracordal) or topical spray and has been investigated for promoting tissue repair in settings such as postoperative fistulas, periodontal bone regeneration, voice cord lesions, and acute ischemic stroke. The product is approved in Japan for certain wound‑healing indications, while other uses remain experimental.
What is Trafermin used for?
Trafermin is educationally associated with: Pressure ulcer / skin ulcer healing, Burn wound healing, Angiogenesis promotion in ischemic tissue, Accelerate wound healing, Periodontal tissue regeneration, Diabetic foot ulcer treatment, Promote granulation tissue formation. Educational only — not medical advice.
How is Trafermin administered?
Recorded routes of administration: Intravenous, Subcutaneous, Topical.
What are the potential side effects of Trafermin?
Reported adverse effects include: Hypersensitivity / allergic reaction, Contact dermatitis, Wound exudate increase, Local erythema, Application site erythema / irritation, Fever, Hypersensitivity systemic reaction. This list is not exhaustive — consult a qualified clinician.
Who should avoid Trafermin?
Recorded contraindications: Pregnancy, Hypersensitivity to trafermin or excipients, Known malignancy or tumor at wound site, Known hypersensitivity to recombinant bFGF, Active malignant neoplasm. Consult a qualified clinician before use.