SYSTEMIC SCLEROSIS · LIMITED CUTANEOUS · DIFFUSE CUTANEOUS · CREST SYNDROME
A physician-led programme targeting fibrosis, vasculopathy and immune dysregulation in systemic sclerosis — designed to soften skin involvement, stabilise organ function and restore physical capacity through individually constructed biological protocols.
Request Medical ConsultationAbout the Condition
Systemic Sclerosis (SSc), commonly referred to as scleroderma, is a chronic autoimmune connective tissue disease characterised by progressive fibrosis of the skin and internal organs, widespread vasculopathy, and immune system dysfunction. The disease results from excessive collagen deposition driven by dysregulated fibroblasts and endothelial damage.
SSc affects the skin, lungs, gastrointestinal tract, kidneys, heart and musculoskeletal system in varying combinations and severity. Pulmonary involvement — interstitial lung disease (ILD) and pulmonary arterial hypertension (PAH) — remains the leading cause of disease-related mortality.
Systemic sclerosis affects approximately 15–25 people per 100,000, with a female-to-male ratio of approximately 4:1. Current pharmacological management relies on immunosuppressants and organ-specific medications. Our programme targets the underlying fibrotic, vascular and immunological mechanisms that drive disease progression.
Limited Cutaneous SSc (CREST)
Skin fibrosis restricted to the hands, forearms, face and feet. Associated with Calcinosis, Raynaud's phenomenon, Esophageal dysmotility, Sclerodactyly and Telangiectasia (CREST). Anti-centromere antibodies are typically positive. Pulmonary arterial hypertension may develop over time, often years after initial diagnosis.
Diffuse Cutaneous SSc
Rapid and widespread skin thickening involving the trunk, upper arms and thighs in addition to distal extremities. Anti-topoisomerase I (Scl-70) antibodies are commonly present. Higher risk of early interstitial lung disease, renal crisis and cardiac involvement. Requires aggressive monitoring and intervention.
Sine Scleroderma
Internal organ involvement characteristic of systemic sclerosis — including pulmonary fibrosis, vasculopathy and GI dysmotility — without clinically significant skin thickening. Diagnosis is often delayed due to the absence of visible skin changes. Serological markers and organ imaging are essential for identification.
Overlap Syndromes
Systemic sclerosis presenting concurrently with features of other autoimmune conditions — most commonly myositis, systemic lupus erythematosus or rheumatoid arthritis. Anti-U1 RNP or anti-PM-Scl antibodies may be present. Management requires addressing multiple disease mechanisms simultaneously.
Our program is individually adapted for all subtypes and all stages of progression.
Important: Each patient is accepted into the programme only after a comprehensive individual medical assessment, which evaluates diagnosis, disease subset, organ involvement, serological profile and overall clinical status.
We do not offer a cure for systemic sclerosis. Our programme is designed to target the fibrotic, vascular and immunological mechanisms driving progression — with the clinical objective of softening skin involvement, stabilising organ function and improving daily quality of life.
Clinical Outcomes
The following data are derived from structured observational analysis of patients treated at BioCells Medical between 2016 and 2025. All figures represent aggregated clinical registry outcomes with longitudinal follow-up. These are observational results — not randomised controlled trial data — and do not constitute a guarantee of therapeutic effect.
22
systemic sclerosis patients treated since 2013
68%
measurable functional stabilisation on mRSS at 3–6 months
−4.2 pts
average mRSS score change at 6 months — vs. expected +1.0 pts natural progression
64%
sustained functional stability with average 2 years of follow-up
76%
showed improvement in one or more measured domains
70%
retained independence in basic activities of daily living (ADL) at 12 months
Joint/organ function (hand mobility and grip strength, oral aperture, FVC on spirometry)
68%
Inflammation (mRSS reduction, skin softening, digital ulcer recurrence)
73%
Systemic symptoms (Raynaud’s episodes frequency and severity, facial skin pliability)
74%
Quality of life (daily hand use, cold intolerance, emotional well-being)
68%
3–8 weeks
Initial functional response
3–6 months
Clinically meaningful change
1–2 years onward
Long-term stability — continuous monitoring
Important: Outcomes depend on SSc subset (limited vs. diffuse), baseline mRSS, degree of organ involvement, disease duration and individual biological response. Individual results may vary significantly.
Find out if our program can help in your specific case. The initial medical consultation is free and carries no obligation.
Request ConsultationPatient Stories
“My skin had become so tight across my hands that I couldn't close a fist or grip anything. After treatment, my occupational therapist measured clear improvement in finger flexion and grip. I can button my own shirt again. That was something I'd accepted I'd lost.”
Patient
Diffuse Cutaneous SSc · France
Every case is assessed individually by our physician team. Request a consultation to discuss your specific situation with our physician team.
Request ConsultationPatient Cases
Documented treatment outcomes recorded by the BioCells Medical team after personalised regenerative medicine protocols.
The BioCells Program
Our systemic sclerosis programme combines five biological components into a single personalised protocol. No two protocols are identical — each is constructed following a detailed medical evaluation of the patient's disease subset, organ involvement, serological markers and clinical priorities.
Minimally invasive administration
Treatment is delivered by intravenous infusion or targeted local injection using specialised medical systems — not surgical instruments.
No general anaesthesia
Important for scleroderma patients with pulmonary or cardiac involvement, where anaesthesia carries elevated risk.
No risk of immune rejection
MSCs are immunoprivileged: they express low levels of HLA-I, lack HLA-II and carry a minimal risk of rejection whether the protocol is autologous or allogeneic. Allogeneic MSC protocols do not require immunosuppression.
Targets fibrosis, vasculopathy and immune dysregulation simultaneously
Rather than addressing a single disease axis, our protocol targets all three core mechanisms of systemic sclerosis — fibrotic, vascular and immunological — within a unified treatment programme.
Complements existing medication
Our programme is compatible with mycophenolate, nintedanib, bosentan and other current standard medications. Patients do not need to discontinue existing treatment before commencing our protocol.
Patients from around the world
We work with patients from around the world. Airport transfers, accommodation, visa support and multilingual coordination are included in every treatment programme.
What It Is
MSCs are multipotent regenerative cells with demonstrated anti-fibrotic, immunomodulatory and pro-angiogenic properties. They are among the most extensively studied cell types in regenerative medicine, with a strong safety profile across autoimmune and fibrotic conditions.
How It Is Done
Cells are collected from the patient's own bone marrow (autologous, approximately 3-5 ml under local anaesthesia) or sourced from a certified donor (allogeneic), depending on individual clinical indications. All cells are then expanded, quality-controlled and tested in our certified Warsaw laboratory before administration.
Biological Mechanisms
How This Helps in Scleroderma
In systemic sclerosis, activated fibroblasts produce excessive collagen while endothelial damage leads to progressive vasculopathy. MSCs address both mechanisms simultaneously — reducing fibrotic signalling, suppressing the immune cascade that maintains fibroblast activation, and supporting the repair of damaged microvasculature. This dual action on fibrosis and vasculopathy is central to our treatment rationale.
Your Medical Board
The exact combination, dosage, sequencing and delivery method of all five components is determined individually by our medical board for each patient. No two treatment protocols are identical. Your programme is constructed based on your specific diagnosis, disease subset, organ involvement, serological markers and clinical priorities.
Your protocol is designed individually. Speak with our medical team to understand what your personalised program would include.
Request ConsultationPatient Journey
Your case is reviewed remotely by our physician team. We assess your diagnosis, current mRSS, pulmonary function data, serological markers and treatment goals. This consultation is free and carries no obligation.
A detailed review of all medical documentation including HRCT imaging, pulmonary function tests, echocardiography and autoantibody panel. Our medical board evaluates eligibility, confirms safety parameters and designs your personalised therapeutic protocol.
Your cells are collected, isolated, expanded and quality-tested in our certified Warsaw laboratory. Each batch receives a full traceability certificate. This stage typically takes 2–3 weeks.
Cells are delivered by intravenous infusion or targeted local administration — no surgery, no general anaesthesia. Airport transfers, accommodation and visa support are included in the programme for international patients.
Structured vascular and musculoskeletal rehabilitation sessions with our specialist, adapted to your current skin involvement, joint mobility and respiratory status. Available at our clinic or remotely coordinated with your local medical team.
Your dedicated coordinator monitors skin scores, pulmonary function, vascular status and overall well-being. A medical-grade wearable bracelet supports continuous health tracking regardless of your location.
The first step is free. Request a medical consultation and our medical consultant will contact you within 24 hours.
Request ConsultationSafety Profile
Cellular therapy is considered safe when delivered under proper medical supervision and according to validated protocols. In our practice, the procedure is well-tolerated by the majority of systemic sclerosis patients.
Temporary mild reactions — such as transient local discomfort at the infusion site, slight fatigue or low-grade temperature — may occur in a minority of patients. These are typically short-lived and indicate active immune engagement.
A final medical assessment is performed on-site before every treatment session. If a patient's status has changed — including pulmonary deterioration or signs of renal crisis — the programme may be temporarily modified or postponed for safety reasons.
All contraindications are evaluated individually. A contraindication in one clinical context does not necessarily preclude treatment in a different context — this is always determined by physician assessment.
Standard Contraindications
Active acute infection or fever
Active malignancy or ongoing chemotherapy / radiotherapy
Scleroderma renal crisis (active or within the past 6 months)
Severe decompensated cardiac or renal failure
Pregnancy
Post-Treatment
Dedicated rehabilitation specialist
monitors skin score progression, vascular status and respiratory function
Personalised rehabilitation programme
adapted to current skin involvement, joint mobility and organ status
Medical-grade wearable monitoring
continuous physiological data collection supporting clinical decision-making
Long-term coordinator support
proactive check-ins, clinical guidance and response to any changes in status
Continued clinical access
our medical team remains available for ongoing reassessment and protocol adjustment
Fibrotic remodelling is a gradual biological process. Measurable changes in skin score and pulmonary function develop over weeks to months. The follow-up period is integral to the treatment — not an afterthought.
Get Started
If you or someone you love has been diagnosed with systemic sclerosis, our medical team is available for a free, no-obligation medical consultation — based on your diagnosis, disease subset and individual clinical profile.
We review every inquiry personally. You will speak with a physician, not an administrator.
Submit your case online or by phone
Our medical consultant contacts you to review your documents
The medical board presents your personalised treatment plan
Request a Consultation
Tell us about your condition. Our medical consultant will contact you within 24 hours to review your documents.
Open Consultation FormMultilingual coordination — English, Italian, French, Russian, Polish
Evidence Base
Our clinical approach is informed by and consistent with published research in the field of regenerative medicine.
