Product Information

Introducing StemOneTM

A first-in-class, standardized, off-the-shelf, allogeneic mesenchymal stem cell therapy, approved
by the Drug Controller General of India(DCGI), for use in the
management of Grade II and Grade III knee OA

Advantages of mesenchymal stem cells1

Abundance and ease of isolation
Can be isolated from various tissues in the body, but the bone marrow and subcutaneous adipose tissues remain the preferential sources of obtaining MSCs, due to their relative abundance
Multilineage differential potential
Have the potential to differentiate into various cell types like osteocytes, chondrocytes, and adipocytes
Immunomodulatory properties
Secrete anti-inflammatory cytokines to suppress both the adaptive and innate immune responses, thus permitting their use as universal donor cells without the need for immunosuppressants
Lack of ethical issues
No ethical concerns like ESCs; can be derived from various body tissues
Low immunogenicity
Immunoprivileged; express very low levels of MHC class I, no MHC class II and do not activate allogeneic lymphocytes

Advantages of mesenchymal stem cells1

Dose2
In non-obese patients with grade 2 & 3 knee OA (BMI<30kg/m2)
Single intra-articular dose of allogeneic mesenchymal stem cells , 25 million cells suspended in 1 ml
CryoStor CS5® plus 1 ml Plasmalyte-A, followed by 2 ml Sodium hyaluronate injection
Storage
−185°C to −196°C
Shelf Life
9 Months

Mechanism of action

StemOneTM leads to cartilage repair and regeneration via three mechanisms.3,4,5
Randomized patient population in the study2

Efficacy2

WOMAC
In a randomized, double-blind, multicentric, placebo-controlled, phase Ill study; the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) composite scores in terms of stiffness, physical function, and their composite in Grade II and Ill knee OA were found to be significantly lower in the StemOne™ arm compared to the placebo arm.
WOMAC (Total)
At 6 months follow up, the percentage of WOMAC - Total scores decreased by 23.64% in the StemOne™ arm as compared to the placebo arm, which further decreased to 45.60% at 1 year follow-up.
WOMAC (Pain)
WOMAC pain subscores at 6 months were decreased by 26.91 % in the StemOne™ arm as compared to the placebo arm, which further decreased to 46.3% at 1 year follow-up.
WOMAC (Stiffness)
Stiffness subscores at 6 months were decreased by 31.9 % in the StemOne™ arm as compared to the placebo arm, which further decreased to 55.13% at 1 year follow-up.
WOMAC (Physical function)
Physical function subscores decreased by 26.6% in the StemOne™ arm as compared to the placebo arm, which further decreased to 45.63% at 1 year follow-up.
VAS
StemOne™ was found to be significantly superior to placebo in reducing pain, as is evident from the Visual Analog Scale (VAS) score changes.
At 6 months: Percentage of VAS score decreased by 39% in the StemOne™ arm as compared to the placebo arm, which was further decreased to 49.3% 1 year follow-up.
80.82% of patients had improvement ~20% in the StemOne™ arm at 1 year follow-up.

T2 Mapping2

MRI T2 mapping is a technique used to analyse the quality of articular cartilage.

Decrease in T2 relaxation time signifies increased collagen and decreased water content of cartilage, i.e., improvement in quality of articular cartilage.

Increase in T2 relaxation time signifies decreased collagen and increased water content of cartilage, i.e., degradation of quality of articular cartilage.

T2 relaxation time is key parameter which can guide about cartilage quality.

T2 relaxation time is maintained with StemOne™ therapy whereas it is significantly increased with placebo therapy. This signifies repair and maintenance of articular cartilage with StemOne™ therapy.

Medial FT compartment - Deep cartilage (T2):

In the StemOne™ arm, the cartilage score was maintained compared to the placebo arm. There was a significant deterioration in the deep cartilage quality in the placebo group whereas the cartilage quality was maintained/improved in the StemOne™ group.
T2 relaxation time:
The T2 relaxation time is maintained with StemOne™ therapy, whereas it is significantly increased with placebo therapy. This signifies repair and maintenance of the articular cartilage with StemOne™ therapy.
a. StemOne™ arm
Medial femoral tibial (femoral) compartment - Deep cartilage T2 relaxation time decreased from 56.27 ms to 44.53 ms
b. Placebo arm
Increasing T2 values is associated with increase in water content and decrease in collagen content
Medial femoral tibial (femoral) compartment- Deep cartilage T2 relaxation time increased from 38.88 ms to 44.31 ms
Cartilage volume:
While only a modest increase in cartilage volume was observed in the placebo arm, a significant increase from approximately 521 to approximately 885 was witnessed in the StemOne™ arm.
Ideal Patient2
StemOne™ to be avoided in
  1. Subchondral sclerosis involving both medial and lateral femorotibial compartments
  2. Complete ACL/PCL tears
  3. Grade 3 complete root tears of the meniscus
Packaging and shipping2
Packaging and shipping2
Patient preparation and administration2

Retrieval of the StemOne™ vial from the cryo-shipper2

Wear the cryogenic gloves before opening the lid of the cryo-shipper
Open the lid of the cryo-shipper
Check the temperature monitor mounted to the lid to ensure that the temperature remains between -185°C & -196°C
The StemOne™ vial is now ready for thawing
Open the vial box and remove the StemOne™ vial out of the box
Remove the canister stand & then remove the vial box out of the canister stand

Thawing and reconstitution2

StemOne™ vial immersed in
pre-heated water bath (37±1°C)
for 3 to 4 minutes
Aspirate 1 ml
of Plasmalyte-A using 5 ml syringe and 18G needle
Flip open the seal of the vial
Inject the aspirated 1 ml Plasmalyte-A into the StemOne™ vial by inserting the 18G needle attached to the 5 ml syringe into the rubber stopper
Rubber stopper
that is visible in
the centre of the
aluminium seal
Attach the given 5 ml syringe to the 18G needle, aspirate the entire suspension into the syringe
StemOne™ injection is ready for injecting followed by HA provided in the kit
StemOne™ administration2
The StemOne™ injection should be administered intra-articularly, using a 5 ml syringe, under all aseptic
precautions.
The StemOne™ injection should be injected immediately after preparation and should not be stored.
The intra-articular injection should be administered using a 2-inch (5.1 cm) 20G needle mostly as a medial or lateral parapatellar injection (an injection into the patellofemoral joint). However, optimal joint positioning and site of needle insertion for the affected knee may vary according to the anatomic and pathologic conditions present.
After injecting StemOne™, the syringe should be detached from the 20G needle (which is not removed from the site of injection) and HA (molecular weight 500,000 – 730,000 Daltons), which is a pre-filled syringe, should be injected through the same needle. Thus, piercing of the needle intra-articularly will be done only once.
The StemOne™ injection should not be used if:
The temperature logger displays a temperature above −185°C, when the StemOne™ vial is being recovered from the cryo-shipper.
The StemOne™ vial is found to be damaged or leaking.
StemOne™ administration2
The StemOne™ injection should not be used if:
Precautions6
0-3 Days post intra-articular injection
Patients should rest for 24 hours after the injection except for bio breaks
0-3 Days post intra-articular injection
Strenuous or prolonged weight-bearing activities must be avoided by the patients for 72 hours after the injection
Patients should stay hydrated, eat regular food & drink plenty of water to promote healing Patients should not take any medications without your knowledge
Only cold packs may be applied, if required, by patients on the injection area Patients should not apply hot packs over, or massage, the injection area
Patients may take bath with lukewarm water after 24 hours Bathing with very hot water must be avoided by patients
Patients should not smoke or drink alcohol
3-14 Days post intra-articular injection
Patients should gradually increase their daily activities and exercise
3-14 Days post intra-articular injection
Patients should avoid drinking alcoholic beverages in the first 7 days
Precautions6
Note: NSAIDs can be used for manangement of pain
Merit of StemOne™ 2
Merit of StemOne™ 2
References:
  1. Loo SJQ, Wong NK. Advantages and challenges of stem cell therapy for osteoarthritis (Review). Biomed Rep. 2021;15:67.
  2. Data on file.
  3. Thej C, Gupta PK. The role of mesenchymal stromal cells in the management of osteoarthritis of the knee. In: Al-Anazi KA, editor. Update on mesenchymal and induced pluripotent stem cells. London: IntechOpen. 2020.
  4. Zha K, Li X, Yang Z, Tian G, Sun Z, Sui X, et al. Heterogeneity of mesenchymal stem cells in cartilage regeneration: from characterization to application. npj Regen Med. 2021;6:14.
  5. Zhang X, He J, Wang W. Progress in the use of mesenchymal stromal cells for osteoarthritis treatment. Cytotherapy. 2021;23:459–70.
  6. Northeast Knee Joint Institute Platelet-Rich Plasma (Post-Procedure) Guidelines. Available from:
    https://nkjinstitute.com/wp-content/uploads/2019/03/PRP-Post-Procedure-Guidelines.pdf Accessed on 19 Sep 2022.

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