| Source & Collection |
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| Harvest locations | Harvest locations Stomach, low back, or thighs More Comfortable | Harvest locations Collected at birth from cord blood Limited to time of birth | Harvest locations Harvested from placenta if whole placenta is collected Different types of products Limited | Harvest locations Pelvis / femur | Harvest locations Stomach, low back, or thighs | Harvest locations Bone, adipose/fat tissue, or umbilical cord |
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| Accepted donors | Accepted donors Parents, children, siblings, recipient Most Flexible | Accepted donors Parent or unknown donor possible with HLA testing | Accepted donors Unknown donors | Accepted donors Same recipient as donor | Accepted donors Same recipient as donor | Accepted donors Varies by source tissue; another patient tissue may be harvested aseptically |
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| Collection limitations & concerns | Collection limitations & concerns Requires harvest and lab delivery | Collection limitations & concerns Limited counts; limited available product; donor matching may be needed Limited Possible Donors | Collection limitations & concerns Possible E. coli contamination | Collection limitations & concerns Limited collections over lifetime; bleeding, pain, or infection risks noted Most Risk | Collection limitations & concerns Outside same-time surgery, use is deemed a drug Surgery-Only Use | Collection limitations & concerns Marker drift, contamination risk, and no U.S. approval Highest Regulatory Risk |
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| Harvest / collection method | Harvest / collection method Fluid is harvested, then the entire harvest is delivered to the lab | Harvest / collection method Fluid is centrifuged, the bottom 2-5 mL is retained, and DMSO is added | Harvest / collection method Placenta tissue is dissected, washed, separated, and then preserved | Harvest / collection method Liquid or pieces of bone marrow are aspirated and then concentrated | Harvest / collection method Liposuction harvest is centrifuged and the pellet is isolated | Harvest / collection method Source tissue is plated, non-adherent cells are removed, and MSCs are expanded in media |
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| Typical collection size / time | Typical collection size / time Entire harvest is processed through the lab | Typical collection size / time Typical total harvest is about 60 cc (mL) / 2 oz | Typical collection size / time Whole placenta harvest when used as source material | Typical collection size / time Harvest takes about 30 minutes | Typical collection size / time About 50 cc of fluid is commonly referenced | Typical collection size / time Expansion depends on repeated passaging cycles |
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| Processing & Storage |
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| Stored frozen | | | | Stored frozen Typically not stored | Stored frozen No; intended for same-time surgical use | |
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| Cell count reporting to patient | Cell count reporting to patient Yes; total nucleated cells, total cells, and live cell counts recorded and provided | Cell count reporting to patient CFU testing is done | Cell count reporting to patient No | Cell count reporting to patient No | Cell count reporting to patient No | Cell count reporting to patient Cells are counted, washed, and reseeded until target counts are reached |
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| Processing summary | Processing summary Patented development in an FDA registered lab with recorded counts | Processing summary Blood banking process centered on centrifugation and cryostorage | Processing summary Decellularization, crosslinking, preservation, and sterilization | Processing summary Typically concentrated before application | Processing summary Centrifuge separation with the pellet considered the final cell fraction | Processing summary MSCs are expanded in rich media with repeated passaging |
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| Storage method | Storage method Labeled and stored in a -80 bio-freezer until requested | Storage method Rate-controlled freezer, then transferred to -80 storage | Storage method Lyophilization, dehydration, or cryopreservation may be used | Storage method Typically not stored | Storage method Not designed for storage; same surgical setting use | Storage method Stored in 10% DMSO in -80 bio-freezers |
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| Storage timeline / access | Storage timeline / access Pulled upon request and delivered to the desired clinic | Storage timeline / access Typically lasts 10-15 years depending on processing | Storage timeline / access Depends on the preservation and sterilization approach | Storage timeline / access Usually not stored | Storage timeline / access Intended for same-time surgical use | Storage timeline / access Stored after expansion and thawed when needed |
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| Quality / safety notes | Quality / safety notes Counts are recorded and provided to the patient | Quality / safety notes CFU typically determines product value | Quality / safety notes Sterilization can alter biological and physical properties | Quality / safety notes Rare bleeding, pain, or infection risks are recorded | Quality / safety notes Harvest pressure can reduce average viability | Quality / safety notes Can only be screened for known cancer cells; contamination remains a concern |
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| Cell Profile |
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| Cell Counts | Cell Counts 30 to 90 million stem cells Most Precise Treatment | Cell Counts 50,000-100,000 stem cells Low Stem Cell Count | Cell Counts No stem cells after processing | Cell Counts Estimated cell counts typically 35,000-50,000 stem cells depending on process | Cell Counts About 50,000 stem cells per 50 cc of fluid | Cell Counts Typically 60,000-100,000 stem cells |
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| Cells retained after processing | Cells retained after processing Yes; PVC as a live cell product | Cells retained after processing Yes | Cells retained after processing Lyophilization and dehydration destroy all cells | Cells retained after processing Yes, but very low MSC portion | Cells retained after processing Yes, but very low MSC portion | Cells retained after processing Yes, numbers depend on process |
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| Nucleated cell counts | Nucleated cell counts Provided for each patient and treatment specifically | Nucleated cell counts Estimated cell counts unless requested | Nucleated cell counts Estimated cell counts | Nucleated cell counts Estimated cell counts | Nucleated cell counts Estimated cell counts | Nucleated cell counts Numbers depend on process |
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| Typical live cell viability | Typical live cell viability Typical live cell counts (CFU) are 95-100% | Typical live cell viability CFU testing is done for live cell counts | Typical live cell viability No cells remain after processing | Typical live cell viability Older patients yield lower live numbers | Typical live cell viability Average viability is around 56% | Typical live cell viability Most effective through early growth cycles and declines with passaging |
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| Stem cell concentration / profile | Stem cell concentration / profile Total stem cell counts typically 30-90 million | Stem cell concentration / profile Typical stem cell counts are 50,000-100,000 | Stem cell concentration / profile No cells at all remain in the final processed product | Stem cell concentration / profile Estimated cell counts typically 35,000-50,000 stem cells depending on process | Stem cell concentration / profile Stem cells are represented by the pellet fraction after centrifuge | Stem cell concentration / profile Typically 60,000-100,000 stem cells |
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| Typical total nucleated cells | Typical total nucleated cells Total nucleated cell counts are typically around 8.5 billion | Typical total nucleated cells Typical total nucleated cell counts are around 470,000 | Typical total nucleated cells No cells remain after processing | Typical total nucleated cells Typical total cell concentrations are around 532,000 | Typical total nucleated cells Document emphasizes total cell yield rather than a separate TNC count | Typical total nucleated cells Counts are expanded to the desired level outside the body |
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| Clinical Use & Approval |
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| Originally developed / primary role | Originally developed / primary role Built around the perivascular fraction where MSCs reside | Originally developed / primary role Initially developed from blood banking for leukemia | Originally developed / primary role Processed for wound coverage and graft-style applications | Originally developed / primary role Initially used as a diagnostic tool for leukemia or lymphoma | Originally developed / primary role Origin of the current stem cell market | Originally developed / primary role Designed to grow stem cells outside the body to increase numbers |
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| Designed / approved for injections | Designed / approved for injections Yes; approved and designed for injections | Designed / approved for injections Not positioned in the document as a routine injection product | Designed / approved for injections Not approved for injections | Designed / approved for injections Typically used for joint or orthopedic injections | Designed / approved for injections Yes, but only in same-time surgical settings | Designed / approved for injections No; not approved for use in the U.S. |
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| Designed / approved for infusions | Designed / approved for infusions Yes; approved and designed for infusions | Designed / approved for infusions Not described as designed for infusions | Designed / approved for infusions Not designed or approved for infusions | Designed / approved for infusions Not designed to be infused | Designed / approved for infusions Not designed or approved to be infused | Designed / approved for infusions Not approved for infusion use in U.S. facilities |
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| Regulatory / coverage notes | Regulatory / coverage notes Covered under malpractice insurance; more delivery methods are in development | Regulatory / coverage notes Based on blood banking guidelines and stored under AABB guidance | Regulatory / coverage notes Only fresh frozen retains original protein and growth factor concentrations | Regulatory / coverage notes Can be covered by insurance | Regulatory / coverage notes Any use outside surgery is deemed a drug by FDA / AATB 351 & 361 | Regulatory / coverage notes Not approved for use at all in the U.S. or FDA-guided facilities |
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