Cellmax™ Freeze Dried Powder

Indication:
For healthcare professionals as an adjuvant to standard wound care in the management of chronic, non-healing wounds in adult patients, including:

• Diabetic Foot Ulcers (DFU)
• Venous Leg Ulcers (VLU)
• Postoperative wounds
• Trauma wounds
• Other chronic non-healing wounds classified as HSPC Class 2 and Class 3 (Harikrishna Peri-wound Skin Classification)

Contraindications:
Cellmax™ Freeze Dried Powder is contraindicated in the following conditions:

• Ischemic wounds prior to effective revascularization
• Neoplastic wounds (wounds associated with malignancy or neoplastic procedures)
• Active infections requiring surgical intervention, such as underlying abscesses and fasciitis requiring incision and drainage
• Underlying osteomyelitis
• Chronic wounds classified as HSPC Class 4 or Class 5, as these types of wounds require more aggressive treatments

Direction for use:

Preparation: Cellmax™ products must be prepared and administered under sterile conditions by trained healthcare professionals.

Reconstitution Instructions:

1. Inspect the vial for integrity. Do not use if packaging is damaged or the expiration date has passed.
2. Remove the protective cap from the vial. Disinfect the rubber stopper with a sterile alcohol swab, swabbing in a circular motion from center outward for 15 seconds. Allow to air dry completely to ensure sterility.
3. Using a sterile syringe, withdraw 2 mL of sterile 0.9% Normal Saline.
4. Inject the 2 mL 0.9% Normal Saline into the vial.
5. Gently swirl the vial until the powder is fully dissolved, forming a clear, sediment-free solution. Do not shake vigorously to avoid denaturing the bioactives.
6. Inspect the reconstituted solution for clarity and absence of particulate matter. Do not use if cloudy or containing foreign particles.
7. Use immediately or store at 2–8°C for up to 12 hours. Discard unused solution after 12 hours.

Subcutaneous Injection Method:

1. Inject (1.0–3.0 mm depth) the reconstituted Cellmax™ solution into the subcutaneous layer at a 45° angle from the wound surface.
2. Begin injections approximately 3 mm from the wound edge.
3. Maintain an injection site spacing of approximately 1 cm, working around the periwound. Any remaining solution may be injected into the wound bed.
4. Cover the wound area with an appropriate secondary dressing and offloading as required.

Dosing Table:

Wound Size	Cellmax™ Amount	Normal Saline	Total Volume	Injection Sites
≤ 5 × 5 cm (≤25 cm²)	1 vial	2 mL	2 mL	6–8 sites, ~0.25 mL each
~7.5 × 7.5 cm (~56 cm²)	1.5 vials (3 mL)	3 mL	3 mL	10–12 sites, ~0.25 mL each
~10 × 10 cm (~100 cm²)	2 vials (4 mL)	4 mL	4 mL	14–16 sites, ~0.25 mL each
> 10 × 10 cm (>100 cm²)	≥3 vials (≥6 mL)	≥6 mL	≥6 mL	24–28 sites, assessed by physician

 

Treatment Schedule: Administer once weekly for up to 12 weeks or until wound closure, with wound assessments at each visit.

Pain Management: For patients with low pain tolerance, apply a local anesthetic (e.g., 5% lidocaine gel) for 10–15 minutes and wipe off before administration.

Precautions:

• Consultation: Consult a provider before use if pregnant, breastfeeding, or for pediatric patients (safety not established).
• Geriatric: Clinical data primarily from adult patients; no specific precautions beyond general wound care.
• Infection Control: Do not apply to wounds with uncontrolled local or systemic infection. Appropriate infection management should be instituted before application.
• Sterility: Reconstitution and administration must be carried out using aseptic technique by trained healthcare professionals.
• Single-patient Use Only: Once reconstituted or opened, the product must be used within 12 hours. Discard any unused portion.
• Allergies: Patients with known hypersensitivity to any components should not be treated. Discontinue use if signs of local or systemic allergic reaction occur.
• Adjunct Use: Intended as an adjunct to standard wound care. There is no data available for the safety of concurrent use with other advanced wound products.

Safety & Quality:

• Biocompatibility: Evaluated under ISO 10993 standards. Testing for cytotoxicity, irritation, and sensitization demonstrated that the products are non-irritant, non-sensitizing, and safe for cutaneous application. Observed in vitro cytotoxicity at high extract concentrations was not clinically relevant. Detailed biocompatibility reports available upon request.
• Adverse Reactions: No adverse side effects, including irritation, sensitization, or allergic reactions, have been reported. Rare cases of hypersensitivity may occur. Discontinue if adverse reactions are observed.
• Drug Interactions: No known drug interactions. The products contain soluble proteins designed for local action and are not intended for mixing with other medicinal products.

Recommended Storage:

• Storage: Store unopened vials at 2–8°C in a dry, dark place. Do not freeze. After reconstitution, use within 12 hours and discard unused portion.
• Shelf Life: 24 months from the manufacturing date.
• Protect from light and moisture. Do not use if packaging is damaged or beyond the expiration date. Discard any product not stored under recommended conditions.

Ingredients:
Bioprotein from Mesenchymal Stromal Cell Secretome, Mannitol, Sodium Chloride.