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Written By:Nishat Arfin|Reviewed By:Viezec Medical Team|
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.

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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.

India
₹1.25–8 lakh
Typical package range
United States
$9,000–$14,000+
Typical treatment range

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.

Understanding the Treatment

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 different pathways are available in India

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.

01

Allogeneic MSC Products

Donor-derived

Regulated, DCGI-approved allogeneic (donor-derived) MSC products are manufactured, dosed, and licensed as a drug and are available for Grade II–III osteoarthritis.

02

Autologous Procedures

Your own cells

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.

The Viezec Approach

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

ProductManufacturer / MarketerApprovalIndicationFormat
StempeucelStempeutics Research (Manipal Group)DCGI, following Phase 2 & Phase 3 trialsGrade II–III knee OAAllogeneic, culture-expanded bone-marrow MSCs
StemOneAlkem LaboratoriesDCGI-approved, 2022Grade II–III knee OASingle intra-articular injection; no anesthesia required
CiplostemCipla (in partnership with Stempeutics)DCGI-approvedGrade II–III knee OA25 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.

Check Your Eligibility →

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.

The Science

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.

01

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.

02

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.

03

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.

Approach 01
DCGI-approved allogeneic MSC
StemOne / Ciplostem
Cell Source
Donor-derived, lab-expanded, off-the-shelf
Same-Day?
Yes — single injection
Regulatory Status in India
Approved drug for Grade II–III OA
Best For
Patients wanting a regulated, standardized, single-dose option

Approach 02
Autologous BMAC
Bone Marrow Aspirate Concentrate
Cell Source
Patient’s own bone marrow, typically collected from the iliac crest
Same-Day?
Yes
Regulatory Status in India
Investigational; physician-directed
Best For
Patients preferring an autologous, or own-cell, source

Approach 03
Adipose-derived SVF
Stromal Vascular Fraction
Cell Source
Patient’s own fat, typically collected through mini-liposuction
Same-Day?
Yes
Regulatory Status in India
Investigational; heterogeneous cell mix
Best For
Patients seeking a higher cell yield than bone marrow and a broader regenerative cell mix

Approach 04
Culture-expanded autologous MSCs
Patient-derived and laboratory expanded
Cell Source
Patient’s own cells, lab-grown to scale
Same-Day?
No — requires lab expansion
Regulatory Status in India
Typically only within approved clinical trials
Best For
Controlled dosing and an approach that has been extensively studied internationally

Important: Regulatory status, availability, eligibility, and treatment protocols can change as evidence and regulations evolve. Individual suitability should be determined through a medical evaluation rather than by the cell source alone.

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?


Kellgren–Lawrence Grade 2 or Grade 3 knee osteoarthritis.


Persistent pain or stiffness despite trying physiotherapy, weight management, and medication.


Focal cartilage defects or post-traumatic cartilage wear for selected autologous protocols.


Willingness to combine treatment with structured rehabilitation and outcome tracking.

When It May Not Be Recommended

×

End-stage Grade 4 OA with severe, diffuse joint-space loss. Knee replacement is usually the better-evidenced option in this situation.

×

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.

DCGI-APPROVED OPTION

Allogeneic Injection

~₹1.25 lakh

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.

AUTOLOGOUS OPTION

BMAC / SVF Package

$4,500–$9,500

Typical treatment package range

Packages may include cell harvest, processing, injection, imaging, and follow-up care.

RESEARCH / TRIAL OPTION

Culture-Expanded MSC

Varies

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

Country
Typical Range (USD)
United States
$9,000–$14,000+
UK / Europe
$10,000–$12,000
Turkey
$8,500–$12,000
India
$2,500–$9,500

Before Choosing a Treatment, Ask These Questions

Is this a DCGI-approved product or an investigational autologous protocol?
What exactly is included in the quoted price?
Can you share published clinical outcomes for this specific product or treatment protocol?

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.

01


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.

02


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.

03


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.

04


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.

FeaturePRPProlotherapyStem Cells
(Autologous)
Stem Cells
(DCGI-approved)
Knee Replacement
Best forEarly OA, mild–moderate painLigament laxity, instabilityCartilage support, inflammation controlGrade II–III OA wanting a single-dose, regulated optionEnd-stage (Grade 4) OA
Evidence baseStrong
Multiple RCTs
Moderate, growingPromising, variable across studiesPeer-reviewed Phase 2/3 dataVery strong
Decades of data
InvasivenessLow
Blood draw + injection
Low
Injections
Low–moderate
Harvest + injection
Low
Single injection, no harvest
High
Surgery
RecoveryDaysDays between sessions1–2 weeks1–2 weeksWeeks 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.

01

Is the specific product or protocol DCGI-approved, or is it an investigational autologous procedure?

02

Can you show published or peer-reviewed outcome data for this exact treatment?

03

What is included in the quoted price — and what isn’t?

04

What are your sterility, GMP, and cell-viability quality controls?

05

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.

01

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.

02

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.

03

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.

04

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.

05

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.

06

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.

07

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.

Evidence-Based Evaluation

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.



Medical report review



Individual eligibility assessment



Clear treatment guidance