Published: November 2, 2025 | Updated: September 5, 2026
DCGI-Approved & Advanced Regenerative Knee Care
Stem Cell Therapy for Knee Osteoarthritis in India – DCGI-Approved & Investigational Regenerative Treatment
Stem cell therapy for knee osteoarthritis uses mesenchymal stem cells — either a DCGI-approved, off-the-shelf allogeneic product or the patient’s own processed cells — injected into the joint to reduce inflammation and support cartilage health. Viezec guides patients through both regulated and investigational pathways in India, with full coordination for international patients.
Trusted stem cell provider for osteoarthritis in India
Stem cell clinic for osteoarthritis in Delhi
Regenerative medicine treatment for osteoarthritis in India
Stem cell hospital for osteoarthritis in Delhi, India
Quick Answer
Stem cell therapy for knee osteoarthritis uses mesenchymal stem/stromal cells (MSCs) — from bone marrow, fat, or an approved lab-grown allogeneic source — injected into the knee joint to reduce inflammation and support cartilage health.
As of 2022, India’s drug regulator (DCGI) approved the country’s first off-the-shelf, allogeneic MSC product for knee OA — marketed as StemOne (Alkem Laboratories) and Ciplostem (Cipla), both built on Stempeutics’ Stempeucel platform — for Grade II and Grade III osteoarthritis.
This sits alongside older, non-approved autologous options such as bone marrow aspirate concentrate (BMAC) and stromal vascular fraction (SVF), which may still be offered in India as investigational, physician-directed procedures.
Important: Treatment availability, regulatory status, eligibility, and cost can vary by product, clinic, protocol, and patient. A medical evaluation is required to determine whether a particular treatment is appropriate.
What Is Stem Cell Therapy for the Knee?
Stem cell therapy for the knee involves injecting mesenchymal stem/stromal cells (MSCs) directly into the joint to calm inflammation, slow cartilage breakdown, and support the joint’s own repair signalling. It’s used for knee osteoarthritis (OA), focal cartilage defects, and post-injury joint wear in patients who haven’t had lasting relief from physiotherapy, weight management, or medication.
Two categories exist in India today, and conflating them is one of the most common sources of confusion online. Understanding which pathway is being considered is important before making a treatment decision.
Allogeneic MSC Products
Regulated, DCGI-approved allogeneic (donor-derived) MSC products are manufactured, dosed, and licensed as a drug and are available for Grade II–III osteoarthritis.
Autologous Procedures
Autologous, physician-directed procedures such as BMAC, SVF, and culture-expanded MSCs use your own cells, which are processed and re-injected, often on the same day.
Important regulatory distinction:
Autologous procedures such as BMAC, SVF, and culture-expanded MSCs remain investigational under Indian and most international regulatory frameworks and should be pursued only within ethical, transparent, outcome-tracking clinical settings.
Clear guidance before you commit
Viezec works with both pathways and will always tell you clearly which category a given protocol falls into before you commit.
2. India’s DCGI-Approved Stem Cell Treatment for Knee OA
This is an important development in regenerative orthopaedics for Indian patients, and it deserves a clear, evidence-based explanation.
Is there an FDA/DCGI-approved stem cell drug for knee osteoarthritis in India?
Yes — as of 2022.
Approved Products & Treatment Platforms
| Product | Manufacturer / Marketer | Approval | Indication | Format |
|---|---|---|---|---|
| Stempeucel | Stempeutics Research (Manipal Group) | DCGI, following Phase 2 & Phase 3 trials | Grade II–III knee OA | Allogeneic, culture-expanded bone-marrow MSCs |
| StemOne | Alkem Laboratories | DCGI-approved, 2022 | Grade II–III knee OA | Single intra-articular injection; no anesthesia required |
| Ciplostem | Cipla (in partnership with Stempeutics) | DCGI-approved | Grade II–III knee OA | 25 million pooled, cultured BM-MSCs co-administered with hyaluronic acid |
What the Trial Data Shows
Stempeutics’ Phase 2 trial, published in Arthritis Research & Therapy, found that a single 25-million-cell intra-articular dose was well tolerated and produced sustained improvements in WOMAC pain, stiffness, and function scores. Phase 3 results were subsequently published in the American Journal of Sports Medicine, a peer-reviewed, indexed journal, providing a stronger clinical evidence base than many autologous protocols currently cite.
Why This Matters for You
This is an off-the-shelf product, meaning there is no need for liposuction or bone-marrow harvesting. Treatment is designed as a single outpatient injection, and manufacturers report effects lasting up to two years or more per dose.
Reported pricing for the injection alone is approximately ₹1.25 lakh (about $1,500) per dose in India, before consultation, imaging, and follow-up care.
What It Doesn’t Do
- It is approved specifically for Grade II–III knee osteoarthritis, not end-stage Grade IV disease.
- It does not replace the need for appropriate physiotherapy and weight management.
- In advanced cases, it does not eliminate the possibility that surgical treatment may be appropriate.
Which Stem Cell Approach May Be Right for You?
Ask your Viezec consultant whether you may be a candidate for a DCGI-approved allogeneic product versus an autologous BMAC/SVF protocol. The appropriate option depends on your OA grade, previous treatments, overall health, and treatment goals.
Important: Regulatory approvals, product availability, treatment indications, pricing, and clinical evidence can change. Eligibility and treatment recommendations should be determined following an individual medical evaluation and review of current regulatory and clinical information.
How It Works: The Science in Plain Terms
Mesenchymal stem cells (MSCs) are being studied for their ability to influence the joint environment through several interconnected biological mechanisms.
Immunomodulation
MSCs release signalling molecules that can help dial down excessive inflammatory activity inside the joint. By influencing this inflammatory environment, they may help reduce pain and swelling.
Paracrine Signalling
MSCs secrete growth factors and cytokines that may communicate with your own joint cells, including chondrocytes and synoviocytes, supporting processes involved in tissue repair and maintenance.
Joint Environment Support
MSC-related changes in the joint environment may influence the composition of synovial fluid, potentially supporting lubrication and reducing some of the biological processes associated with cartilage breakdown in osteoarthritis.
An important distinction:
MSCs are not simply replacing damaged cartilage wholesale. Their potential effects are thought to involve communication with cells and tissues already present in the joint, helping influence inflammation, repair signalling, and the overall joint environment.
Types of Stem Cell Approaches Compared
Different stem cell approaches vary in their cell source, preparation time, regulatory status, and potential clinical use. The comparison below provides a general overview of the main approaches being considered for regenerative treatment.
Who Is a Candidate?
Stem cell therapy for knee osteoarthritis is not appropriate for everyone. Eligibility depends on the severity of joint damage, symptoms, previous treatments, overall health, and the treatment protocol being considered.
Who May Be a Good Candidate?
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Kellgren–Lawrence Grade 2 or Grade 3 knee osteoarthritis.
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Persistent pain or stiffness despite trying physiotherapy, weight management, and medication.
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Focal cartilage defects or post-traumatic cartilage wear for selected autologous protocols.
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Willingness to combine treatment with structured rehabilitation and outcome tracking.
When It May Not Be Recommended
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End-stage Grade 4 OA with severe, diffuse joint-space loss. Knee replacement is usually the better-evidenced option in this situation.
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Active joint infection, uncontrolled bleeding disorders, or active malignancy. Specific exclusions may vary by treatment protocol.
Quick Self-Check
These questions can help you understand whether a clinical eligibility review may be worthwhile:
✓ Has physiotherapy, weight management, or medication been tried for a meaningful period?
✓Is your knee damage early-to-moderate rather than end-stage?
✓Are you open to structured follow-up, including WOMAC or KOOS scoring, to track changes over time?
Cost of Stem Cell Therapy for Knee OA in India
The cost of stem cell therapy for knee osteoarthritis in India varies depending on the type of cells used, whether the treatment is approved or investigational, the number of knees treated, and what is included in the treatment package.
Allogeneic Injection
Approximately ~$1,500 for the product per knee
Total treatment packages with consultation and imaging typically range from
$2,500–$4,500.
Single dose; manufacturer-reported effect duration up to approximately 2 years.
BMAC / SVF Package
Typical treatment package range
Packages may include cell harvest, processing, injection, imaging, and follow-up care.
Culture-Expanded MSC
Depends on the specific clinical trial
Availability is generally limited to specific research centres, with some approved trials offering treatment on a subsidised basis.
International Pricing Comparison
Before Choosing a Treatment, Ask These Questions
Note: Treatment costs can vary based on the patient’s condition, treatment protocol, number of knees treated, hospital charges, diagnostic testing, and follow-up requirements. The figures above are general ranges and should not be considered a personalised quotation.
Success Rates & Published Evidence
When evaluating regenerative treatments for knee osteoarthritis, published clinical evidence is more meaningful than headline success rates. The available evidence varies by treatment type, cell source, dose, study design, and how outcomes are measured.
Stempeucel: Phase 2 Evidence
Stempeucel’s Phase 2 trial data, published in Arthritis Research & Therapy, showed that a single 25-million-cell dose was well tolerated, with sustained improvement in WOMAC scores over the follow-up period.
Phase 3 Results
Phase 3 results were published in the American Journal of Sports Medicine, a peer-reviewed orthopaedic sports-medicine journal. This provides a stronger published evidence base than the largely promotional or clinic-reported data often available for autologous regenerative protocols.
StemOne / Stempeucel-OA: Long-Term Durability Data
A 24-month peer-reviewed follow-up of the Phase 3 study, published in Osteoarthritis and Cartilage Open, reported durable improvements in pain and function through 2 years, with imaging showing cartilage preservation in the treated group versus progressive degeneration in the placebo group. See the published 24-month results.
As with any study, patients should ask their provider how these outcomes were measured and whether they apply to their specific OA grade before treatment.
Autologous BMAC & SVF
For autologous BMAC/SVF, results are more heterogeneous across studies because of differences in cell counts, harvesting methods, processing techniques, and outcome definitions. A 2022 systematic review in the American Journal of Sports Medicine found BMAC improved pain and patient-reported outcomes short- to mid-term, but did not demonstrate clinical superiority over other biologic treatments. This is why asking a provider “How do you define success, and can I see your outcome data?” can be more informative than relying on marketing claims published on a clinic website.
Important: Individual results vary by age, osteoarthritis grade, overall health, treatment protocol, and adherence to post-procedure rehabilitation. No regenerative treatment — whether approved or investigational — should be presented as a guaranteed cure.
Stem Cells vs PRP vs Prolotherapy vs Knee Replacement
Choosing a treatment for knee osteoarthritis depends on the severity of joint damage, symptoms, treatment goals, recovery expectations, and overall health. The comparison below provides a general overview of how commonly considered options differ.
| Feature | PRP | Prolotherapy | Stem Cells (Autologous) |
Stem Cells (DCGI-approved) |
Knee Replacement |
|---|---|---|---|---|---|
| Best for | Early OA, mild–moderate pain | Ligament laxity, instability | Cartilage support, inflammation control | Grade II–III OA wanting a single-dose, regulated option | End-stage (Grade 4) OA |
| Evidence base | Strong Multiple RCTs |
Moderate, growing | Promising, variable across studies | Peer-reviewed Phase 2/3 data | Very strong Decades of data |
| Invasiveness | Low Blood draw + injection |
Low Injections |
Low–moderate Harvest + injection |
Low Single injection, no harvest |
High Surgery |
| Recovery | Days | Days between sessions | 1–2 weeks | 1–2 weeks | Weeks to months |
| Regulatory status in India |
Standard clinical use |
Standard clinical use |
Investigational |
DCGI-approved drug |
Standard surgical care |
← Swipe horizontally to compare all treatment options →
Important: Treatment suitability depends on factors such as the severity of osteoarthritis, imaging findings, symptoms, previous treatments, and overall health. This comparison is for general information and should not replace an individualized evaluation by a qualified medical professional.
Want to understand which option may suit your condition?
Read more: Stem Cell Therapy vs PRP Therapy — Which Suits You?
How to Choose a Provider
Before booking treatment, take time to evaluate the provider carefully. Ask every clinic these five questions and look for clear, evidence-based answers.
Is the specific product or protocol DCGI-approved, or is it an investigational autologous procedure?
Can you show published or peer-reviewed outcome data for this exact treatment?
What is included in the quoted price — and what isn’t?
What are your sterility, GMP, and cell-viability quality controls?
What’s your plan if the treatment doesn’t deliver the expected benefit?
A trustworthy centre will answer all five without hesitation.
Frequently Asked Questions
Clear answers to common questions about stem cell therapy for knee osteoarthritis in India.
Is stem cell therapy for knee osteoarthritis approved in India?
Yes — India’s DCGI approved an allogeneic MSC product (Stempeucel platform, marketed as StemOne/Ciplostem) for Grade II–III knee osteoarthritis in 2022. Separately, autologous procedures such as BMAC and SVF are offered as investigational, physician-directed treatments outside formal drug approval.
How much does stem cell therapy for the knee cost in India?
The DCGI-approved single-injection product costs roughly ₹1.25 lakh for the product itself, while full packages including consultation, imaging, and follow-up typically range from $2,500–$4,500. Autologous BMAC/SVF packages typically cost $4,500–$9,500.
How long do results last?
Manufacturer-reported data for the approved allogeneic product suggests effects lasting up to two years or more per dose. Results with autologous protocols vary more and may last from several months to a few years, depending on factors such as osteoarthritis severity, activity level, and lifestyle.
Who should NOT get stem cell therapy for the knee?
Patients with end-stage (Grade 4) osteoarthritis, active joint infection, uncontrolled bleeding disorders, or active cancer are generally not candidates. For end-stage disease, knee replacement is usually the better-evidenced treatment option.
Is stem cell therapy for knee osteoarthritis safe?
When performed in accredited facilities using appropriately manufactured products or properly processed autologous cells, safety profiles are generally favorable. Mild, short-term swelling or discomfort can occur. Serious complications are uncommon but possible, so treatment should follow an appropriate medical evaluation.
How is this different from PRP?
PRP concentrates your own platelets and growth factors; it does not introduce stem cells. Stem cell therapy uses mesenchymal stem cells (MSCs), which are being studied for their potential to modulate inflammation and support tissue repair. Some treatment protocols may use PRP alongside other regenerative approaches.
Why choose Viezec?
Viezec connects patients with both DCGI-approved treatment pathways and ethically supervised autologous protocols, with transparent guidance on which category may apply to your case. Our approach emphasizes realistic outcome expectations, appropriate medical evaluation, and full-cost clarity before you commit to treatment.
Take the First Step
Whether you’re a candidate for India’s DCGI-approved single-injection therapy or a supervised autologous protocol, the right first step is an evidence-based eligibility review — not a generic sales pitch.
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Medical report review
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Individual eligibility assessment
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Clear treatment guidance