Knee Osteoarthritis Stem Cell Protocol

Investigational Mesenchymal Stem Cell Intervention for Knee Joint Care

Important Medical Notice:

The intra-articular application of mesenchymal stem cells for knee osteoarthritis remains an investigational procedure. It must not be presented as a cure, guaranteed cartilage regeneration, meniscal repair, or a direct substitute for therapeutic exercise, weight management, appropriate analgesia, or indicated joint replacement surgery (arthroplasty).

Institutional Provider Details:

  • Legal Entity: STEM CELLS KYRON COLOMBIA SCKC

  • Facility Address: Calle 6 Oeste #24f-13, Cali, Colombia

  • Medical Director: Dr. Carlos Eduardo Rojas Martínez, MD (CEO)

  • Cell Processing Laboratory: TRUSTEM BANK

  • Clinical Patient Manager: Daniel Sanz

SCOPE OF SERVICE

(INCLUSIONS & EXCLUSIONS)

Included in the Package

Exclusions & Out-of-Pocket Expenses

CLINICAL ELIGIBILITY & REQUIRED DOCUMENTS

Potential Candidates for Evaluation:

  • Adults with symptomatic knee osteoarthritis showing a clear correlation between joint pain, functional limitation, physical examination, and weight-bearing X-rays.

  • Documented insufficient response to appropriate conservative management.

  • Capacity to provide informed consent and adhere to post-procedure care and remote follow-up.

  • Realistic functional goals with explicit acceptance that structural cartilage regeneration cannot be guaranteed.

Situations Requiring Additional Evaluation or Exclusion:

    • Active fever, systemic infection, skin infection/cellulitis near the knee, or suspected septic arthritis.

    • Mechanical locked knee, acute fracture, major ligamentous instability, or sudden loss of weight-bearing capacity without prior workup.

    • Uncontrolled inflammatory/crystal arthritis, active hemarthrosis, bone tumor, extensive osteonecrosis, or decompensated systemic disease.

    • Unmanageable coagulopathy, significant immunosuppression, pregnancy, or known allergies to protocol components.

    • Advanced end-stage osteoarthritis with severe malalignment where joint replacement surgery is clearly indicated.

  • Detailed medical history documenting affected knee compartments, symptom duration, pain patterns, morning stiffness, locking, and instability.

  • Complete list of current medications, anticoagulants, antiplatelet drugs, supplements, and known allergies.

  • History of prior knee surgeries, arthroscopies, meniscectomies, joint injections, and physical therapy records.

  • Recent weight-bearing knee X-rays (AP/PA in flexion, lateral, and patellofemoral views); full-leg alignment radiographs, ultrasound, or MRI when clinically indicated.

  • Emergency contacts and government-issued identification.

PROTOCOL SPECS & 4-DAY TIMELINE

Cellular Product Specifications:

  • Cell Type: Umbilical Cord-Derived Mesenchymal Stem Cells (UC-MSCs).

  • Manufacturing Laboratory: TRUSTEM BANK.

  • Reference Dose: 50 Million viable cells per affected knee.

  • Quality Assurance: Each batch includes verified post-thaw viability, sterility, endotoxin, and mycoplasma clearance certificates.

  • Administration: Intra-articular injection performed under direct ultrasound guidance.

4-Day Clinical Itinerary:

  • Pre-Travel (1 Week Prior): Remote medical file review, clinical pre-selection, and itemized budget approval.
  • Day 1 (Arrival in Cali): On-site physical examination, joint assessment, and protocol testing.
  • Day 2 (Procedure Day): Ultrasound-guided intra-articular administration and post-procedure clinical monitoring.
  • Day 3 (Local Observation): Local symptom evaluation, joint tracking, and mobility assessment.
  • Day 4 (Travel Clearance): Final medical review, discharge documentation, and authorization for return flight.
  • Remote Follow-Up: Scheduled clinical scale evaluations at Weeks 4, 14, 36, and 52.

POST-PROCEDURE RECOVERY & RISK DISCLOSURE

Post-Procedure Recovery Guidelines:

  • First 24–48 Hours: Follow all local observation instructions. Seek immediate emergency care if experiencing high fever, rapidly increasing severe pain, marked joint redness/warmth, large swelling, inability to bear weight, or allergic symptoms.

  • First Week: Maintain progressive mobilization as instructed. Keep the injection site clean and dry. Avoid unapproved heavy loads or strenuous exercise.

  • Distinguishing a Non-Infectious Flare from Septic Arthritis: Early mild pain or joint effusion can occur as a transient inflammatory reaction (flare). However, progressive severe pain, redness, systemic fever, or total inability to support weight require urgent clinical evaluation to rule out septic arthritis.

General Risks and Possible Complications:

  • Local injection site pain, bruising, bleeding, or mild swelling.

  • Transient low-grade fever, headache, nausea, or fatigue.

  • Allergic or inflammatory reactions.

  • Infection, septic arthritis, or soft tissue infection (requires immediate medical intervention).

  • Lack of clinical benefit, disease progression, or financial loss.

FREQUENTLY ASKED QUESTIONS

1. Is stem cell therapy approved as a routine treatment for knee osteoarthritis?

No. It is an investigational protocol and not an established routine treatment. Its regulatory context and specific product characteristics must be fully explained before informed consent.

2. What does the starting price include?

The $5,000 USD figure is an initial planning estimate. You will receive a signed, itemized quote separating medical fees, laboratory product charges, testing, and follow-up.

3. Can this protocol cure osteoarthritis or regenerate cartilage?

No. It cannot promise guaranteed cartilage regeneration, meniscal repair, structural reversal, or the absolute avoidance of joint replacement surgery.

4. What information should I request regarding the cellular product?

You should request written details on cell source, donor screening, laboratory provider, cell viability, sterility, endotoxin testing, dosage, and release criteria.

5. How long must we stay in Cali, Colombia?

The recommended baseline stay is 4 days, but flexibility is essential depending on whether administration is unilateral or bilateral, post-procedure reaction, and travel readiness.

6. Should I stop my current medications or anti-inflammatories?

Do not stop or modify prescribed medications, analgesics, or anticoagulants on your own. The medical team will provide written instructions before and after the procedure.

7. How do doctors distinguish a post-injection flare from an infection?

Mild early discomfort can be inflammatory, but high fever, spreading redness, severe warmth, or severe inability to bear weight demand urgent emergency evaluation to rule out septic arthritis.

8. Does a registered clinical trial guarantee that the treatment works?

No. Clinical trial registry reflects research activity but does not equal regulatory approval, safety confirmation, or proven efficacy for an individual patient.

9. How can I verify the clinic and cellular laboratory?

You may request current documentation regarding provider accreditation, treating physician licenses, laboratory quality certifications, and emergency referral protocols.

10. Should I obtain an independent medical opinion before traveling?

Yes. Consulting your home primary care physician or orthopedist helps evaluate health risks, standard alternatives, travel safety, and ongoing care.

PRE-DECISION CHECKLIST

Request Your Knee Joint Evaluation

Submit your medical details and recent X-rays. Our clinical team will review your candidate status for our ultrasound-guided intra-articular protocol.

Call us

+ (1) 305 400 1476
+ (57) 315 399 5608

Email us

daniel@stemcellskyroncolombia.com drc@stemcellskyroncolombia.com

Visit us

Cl. 6 Oe. #N° 24F - 13, Miraflores, Cali, Valle del Cauca