Medical Policy
Subject: Autologous Adipose-derived Regenerative Cell Therapy
Document #: MED.00132Publish Date: 01/30/2025
Status: RevisedLast Review Date: 11/14/2024
Description/Scope

This document addresses autologous adipose-derived regenerative cell therapy (for example, Lipogems system, Lipogems International, Norcross, GA). This service involves the removal of a heterogenous mixture of cells derived from an individual’s adipose (fat) tissue in one part of their body and injecting it into another part of their body.

Note: This document does not address gender affirming care. Criteria for gender affirming care are found in applicable guidelines used by the plan.

Note: For related documents see the following:

Position Statement

Investigational and Not Medically Necessary:

Autologous adipose-derived regenerative cell therapy is considered investigational and not medically necessary for all indications.

Rationale

Autologous adipose-derived regenerative cell therapy, also referred to as autologous cellular implant derived from adipose tissue, involves the removal of a heterogenous mixture of fat-derived cells from one part of the body and injecting it into another part of the body. The collected cells may include adult stem cells, vascular endothelial cells, vascular smooth muscle cells, fibroblasts, T-regulatory cells, and macrophages. Although autologous adipose-derived regenerative cells are of mesodermal origin, they have the potential, under the proper conditions, to differentiate into multiple lineages of adipogenic, chondrogenic, osteogenic, myogenic, cardiomyogenic, and neurogenic cells. Autologous adipose-derived regenerative cells have been investigated as a potential source of regenerative medicine for a wide range of indications including but not limited to erectile dysfunction, urinary incontinence, soft tissue therapy for scarred or irradiated tissue or chronic wounds (Tabit, 2012).

Much of the literature on autologous adipose-derived regenerative cells are case series (Gotoh, 2019; Haahr, 2018; Laureti, 2019; Naldini, 2018; Panchal, 2018) which lack comparison groups, and which are not randomized or controlled for confounders or other potential sources of bias. These studies do not permit reasonable conclusions regarding the net health benefit of this intervention.

There have been some randomized trials published evaluating autologous adipose-derived regenerative cell therapy.

Granel (2015) reported the results of a randomized-controlled trial that investigated the safety, tolerability and efficacy of autologous adipose-derived stromal vascular fraction injections in the fingers of individuals with scleroderma. The study was an open-label, single arm study, at one study site. The 12 participants were followed for 6 months. A total of four minor adverse events were reported and resolved spontaneously. The authors reported a significant improvement in hand pain and disability. Raynaud's phenomenon, finger edema and quality of life was also observed. The authors concluded that the potential efficacy needs confirmation in additional studies, more specifically, randomized placebo-controlled trials with more robust populations.

Daumas (2017) described the longer follow-up observations at 22 and 30 months after initial treatment for the same 12 participants reported on by Granel and colleagues (2017) above. Multiple participant-reported outcomes showed persistent improvement, in comparison with baseline assessments. In addition to a decrease in the number of digital ulcers reported, improvement was also demonstrated in mobility, strength and fibrosis of the hand. None of the 8 participants who had previously received the subcutaneous injection of autologous adipose-derived stromal vascular fraction required new infusion. All of the enrolled participants had surgery, and there were no dropouts or participants lost to follow-up. No severe adverse events occurred during the procedure and follow-up. The authors were in favor of a review of the results of the two ongoing studies before final determination of “the place of this innovative therapy” for individuals with scleroderma.

Hurd (2020) reported the results of a randomized trial in 20 individuals with symptomatic, partial-thickness rotator cuff tears. Participants were randomized to treatment with either with fresh, uncultured, unmodified, autologous adipose-derived regenerative cells (experimental group) or a single injection of methylprednisolone plus bupivacaine (control group). A total of 84 participants were assessed for eligibility, with 64 excluded. The Randomization included 20 subjects, with 12 in the experimental group and 8 in the control group. One participant was lost to follow-up in the experimental group and 2 in the control group. Follow-up was 12 months. The modified intent-to-treat population included 16 subjects total; 11 experimental group and 5 control group participants. The authors stated that the study was not powered to assess outcomes. The primary clinical outcome was the occurrence of adverse events, which was assessed immediately after treatment and weeks 3, 6, 9, 12, 24, 32, 40, and 52 post-treatment. Treatment emergent adverse events (TEAEs) were reported in all participants, with a total of 34 events in the experimental group and 13 in the control group. TEAEs possibly or probably related to the treatments included pain (musculoskeletal, extremity and abdominal), dyspnea, myocardial infarction, and progression to full thickness rotator cuff tear. Secondary clinical outcomes included changes in the American Shoulder and Elbow Surgeons Society standardized shoulder assessment form (ASES total score), Short Form-36 total score, Visual Analogue Scale for pain (VAS), and size of the rotator cuff tear measured on MRI. The mean ASES total score in the experimental group increased from 58.7 ± 5.8 at baseline to 86.1 ± 4.9 at 24 weeks and 89.4 ± 4.9 at 52 weeks post-treatment. In the control group, ASES total scores increased 50.6 ± 6.7 at baseline to 60.8 ± 6.2 at 24 weeks and 68.4 ± 4.4 at 52 weeks post-treatment. Differences between the groups at 24 weeks and 52 weeks were statistically significant (p<0.05). No significant differences were reported with regard to SF-36, VAS, or MRI results (p>0.05). The results of this trial do not provide generalizable data regarding the clinical utility of fresh, uncultured, unmodified, autologous adipose-derived regenerative cells for the treatment of rotator cuff repairs. Additional data is needed from robust, well-designed trials to elucidate that information.

Sembronio (2021) compared the use of Lipogems technology injected after arthrocentesis to standard treatment with hyaluronic acid in a randomized controlled trial (RCT) involving 20 individuals with degenerative temporomandibular joint disease. In both groups, pain reduction and mouth opening significantly improved compared with the preoperative condition (p=0.001). At 6-month follow-up, there was only a statistically significant improvement of mouth opening (p=0.327). Overall, statistical analyses showed that the intervention group had more procedures that met success criteria than the control group (p=0.018).

Wang (2021) conducted a randomized pilot trial comparing the feasibility and efficacy of improving fat retention using adipose-derived stem cell (ADSC)-assisted, autologous adipose-derived stromal vascular fraction (SVF)-assisted, and conventional autologous fat grafting methods in individuals with facial localized scleroderma. The study involved 18 participants followed for 6 months. Volume retention was measured by MRI and clinical photographs. At 6-months follow-up, fat retention in the ADSC-assisted group was significantly higher than the SVF-assisted group (p=0.0004) and conventional autologous fat grafting group (p<0.0001). There was also a significant difference in observed fat retention in the SVF-assisted group compared to the conventional group (p=0.0346). However, the findings in this study are limited by the sample size and short-duration of follow-up. The clinical significance of the findings is also uncertain.

Daumas (2022) reported the results of a prospective double-blind, placebo controlled RCT involving 40 participants with systemic sclerosis who received treatment with either placebo or adipose tissue-derived stromal vascular fraction injections into the fingers. Each group included 20 participants, all of whom were followed for 6 months post-treatment. Participants had a score of ≥ 9 on the European Alliance of Associations for Rheumatology/ American College of Rheumatology (EULAR/ACR) Classification and a Cochin Hand Function Scale (CHFS) score above 20/90 despite optimal medical treatment. One participant was lost to follow-up after 4 months due to death unrelated to the treatment protocol. The authors were not clear regarding which group this participant belonged. The intent-to-treat analysis was based on a total of 39 subjects. While improvement was seen in both groups for most parameters, no significant between-group differences were reported with regard to the rate of adverse events (19 in the adipose group and 16 in the placebo group). Only one serious adverse event was attributed to the surgical procedure, hypoxemia during the surgical process in a placebo group participant. There were no between-group differences with regard to the primary endpoint of CHFS outcome at either 3 or 6 months (p=0.274 and p=0.833, respectively). Similarly, no significant no between-group differences were noted for secondary outcome measures, including global disability related to systemic sclerosis (SHAQ, p=0.415), hand pain severity (VAS, p=0.209), dorsal hand and finger skin sclerosis (mgs applied to hands, p=0.384) and Raynaud’s phenomenon severity (p=0.255). The number digital ulcers was likewise not significantly different between groups at 3 and 6 months (p=0.402 and p=0.149). The authors commented that the statistical power of these comparisons is very low given the small sample size and differences between disease subtype in each treatment group. The authors noted that the results of this trial demonstrated improvement in hand function in both groups with no superiority in either group, and that studies with larger participant pools were needed to elucidate any benefit to adipose tissue-derived stromal vascular fraction injections into the fingers for the treatment of systemic sclerosis.

Iglesias (2023) reported the results of an open-label RCT that evaluated the safety and clinical effects of fat micrografts plus autologous adipose-derived stromal vascular fraction injections administration into the right hand of twenty participants with systemic sclerosis. Participants in the control group continued to receive only medical treatment. Digital oximetry, pain, Raynaud phenomenon, digital ulcers number, mobility, thumb opposition, vascular density of the nail bed, skin affection of the hand, serologic antibodies, hand function, and quality of life scores were gauged in both groups. The results of the intervention were evaluated with the Wilcoxon rank test, and the differences between the control and experimental groups at 0 days and 168 days were evaluated with the Mann-Whitney U test. No adverse events were observed in either group. At the end of the study, statistically significant improvements were detected in pain levels (p<0.05) and number of digital ulcers (p<0.01) in the experimental vs. control group. The authors concluded that adipose derived-stromal vascular fraction plus fat micrografts injections is a safe and reproducible technique. Pain and digital ulcers in the hands of participants with systemic sclerosis can be treated with this technique plus conventional medical treatment. Limitations of the study include its lack of blinding and small sample size. While the number of digital ulcers was statistically lower in the experimental group compared to the control group at the end of the study, these results must be interpreted with caution because the researchers did not assess the number of digital ulcers existing at baseline and at the end of the study in each participant. Additionally, although only one participant in the control group was lost, the loss of a single participant is significant considering the size of the sample.

Khanna (2023) reported the results of the Scleroderma Treatment with Celution Processed Adipose Derived Regenerative Cells (STAR) Trial, a prospective double-blind, placebo controlled RCT involving 40 participants with systemic sclerosis who received treatment with either placebo or adipose tissue-derived stromal vascular fraction injections into the fingers. The trial involved 88 participants, 48 who received adipose injections and 40 received placebo treatment. All participants completed the 24 week endpoint, and one participant in the adipose group was lost to follow-up at the 48 week follow-up. The authors reported that there were no significant differences between groups for the primary endpoint, CHFS, at either follow-up time (p=0.442 at 24 weeks and p=0.299 at 48 weeks). A prespecified analysis of sclerosis subtypes, diffuse cutaneous SSc (dcSSc) and cutaneous SSc (lcSSc), did not elucidate any significant outcomes between subtypes in the between treatment analysis or the between subtype analysis. A significant difference between groups was reported with regard to the secondary endpoint Health Assessment Questionnaire disability index at 48 weeks (HAQ DI, p=0.044) although the clinical relevance of this difference is unclear. No significant differences between groups were reported for any other secondary endpoint at 48 weeks, including Raynaud’s Serious Condition Score (RCS, p=0.305), EQ-5D (p=0.104), Assessment of Systemic Sclerosis Activity (p=0.76 for participant assessments and p=0.38 for physician assessments). Serious adverse events occurred in 1 adipose group and 5 placebo group participants, but none were deemed associated with the assigned treatments. Adverse events of any grade deemed potentially related to the liposuction procedure were reported in 3 participants (9%) in the adipose group and 3 participants (16%) in the placebo group. Aside from the one serious event noted above, all events were deemed mild and were resolved within 36 days. Of these, 6 in the adipose group was regarded as potentially related to overall treatment and as was one in the placebo group. The authors concluded that the primary endpoint was not met in this trial, but that adipose tissue-derived stromal vascular fraction injections for treatment of finger morbidity in individuals with systemic sclerosis was feasible, but further trials were warranted.

Ulivi (2023) reported a prospective, unblinded RCT involving 78 participants with grade 3-4 knee osteoarthritis treated with either arthroscopic debridement alone or arthroscopic debridement with injections of Lipogems-derived adipose tissue (n=39 in each group). The final analysis at 24 months included 55 (70.5%) participants (27 in the debridement-only group and 28 in the Lipogems group). A total of 4 serious adverse events were reported, all in the Lipogems group, but none were determined to be related to the study treatment. At 6 months, significant improvements were reported in both groups, with only significant differences reported in the Knee Injury and Osteoarthritis Outcome Score-Physical Function Shortform (KOOS-PS) functional subscale in favor of the Lipogems group (p=0.005). At 24 months, both groups demonstrated significant improvements on all measures, but no significant differences between groups were reported on any assessments, including the KOOS-PS, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), SF-12 survey, or Knee Society Score (KSS) tool. MRI evaluations at 6-month follow-up demonstrated significant differences between groups in terms of T2 mapping score, within both the anterior/posterior medial condyle and anterior/posterior lateral condyle compartments (p<0.001). No significant differences were found between groups in the anterior or posterior medial tibia or anterior lateral tibia compartments. No significant differences between groups were reported with regard to serum biomarker levels of cross-linked C-telopeptide of Type II collagen (CTx-II) or N-terminal procollagen III propeptide (PIINP). The authors state that the significant loss to follow-up at 24 months and lack of blinding as limitations in this study. Given these methodological concerns, the impact of Lipogems on net health outcomes in individuals with rotator cuff tears remains unclear.

Autologous adipose-derived regenerative cell therapy has been proposed as a treatment for a wide array of other indications, including lymphedema, various musculoskeletal indications, urinary incontinence, and vocal fold defects. These studies have been methodologically weak and subject to multiple sources of bias and confounding resulting in findings that are non-generalizable (Alentorn-Geli, 2019; Fujita, 2023; Guillaumes, 2024; Hogaboom, 2021; Jørgensen, 2021; Mattei, 2020; Vieira, 2024). Robust, well-designed trials are needed to elucidate the benefits of Autologous adipose-derived regenerative cell therapy for the treatment of these conditions.

Conclusion

At this time, credible scientific evidence published in peer-reviewed medical literature remains limited and does not permit reasonable conclusions concerning net health outcomes as a result of autologous adipose-derived regenerative cell therapy. Large, well designed and conducted double blind RCTs would be helpful in elucidating the potential benefits of this therapy, especially in light of the heterogenous results demonstrated in the current body of evidence.

Background/Overview

Autologous Adipose-derived Regenerative Cell Therapy

Autologous adipose-derived regenerative cell therapy involves the injection of a heterogenous mixture of fat-derived cells, either unprocessed or minimally processed, from one part of a person to another part of the same person. This treatment method has been proposed as a regenerative treatment of a wide variety of indications, including orthopedic injuries. One commercially available device used to produce this type of therapeutic product is named Lipogems (Lipogems International, Norcross, GA), which is used to produce “microfractionated minimally manipulated adipose tissue.”

This device was cleared in 2016 by the U.S. FDA (K161636) with these indications:

The Lipogems System is a sterile medical device intended for the closed-loop processing of lipoaspirate tissue in medical procedures involving the harvesting, concentrating and transferring of autologous adipose tissue harvested with a legally marketed lipoplasty system. The device is intended for use in the following surgical specialties when the transfer of harvested adipose tissue is desired: orthopedic surgery, arthroscopic surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and plastic and reconstructive surgery when aesthetic body contouring is desired. Only legally marketed accessory items, such as syringes, should be used with the system. If harvested fat is to be transferred, the harvested fat is only to be used without any additional manipulation.

Scleroderma

Scleroderma (also known as crest syndrome) is a chronic (long-lasting) connective tissue disease generally classified as one of the autoimmune rheumatic diseases. Symptoms of scleroderma may include tightening of the skin, joint pain, an exaggerated response to cold and heartburn. There are two principal types of scleroderma: localized, which affects only the skin; and systemic which affects the skin as well as the blood vessels and internal organs. The seriousness of scleroderma will vary depending upon the area(s) of the body that are affected.

Definitions

Autologous adipose-derived regenerative cell therapy: A medical therapy proposed to treat a wide array of conditions using fat cells from an individual which are extracted from one part of the body and then injected into another. In some cases, the fat cells are processed in some fashion prior to reinjection.

Regenerative therapy: A cell therapy, therapeutic tissue engineering product, human cell and tissue product, or any combination product using such therapies or products that intends to modify, treat, reverse, or cure a disease or condition by contributing, inducing or promoting tissue healing. Regenerative therapies may purport to promote the growth and division of repair cells or mediate the inflammatory process associated with an injury or disease, or produce a regenerative effect via their direct incorporation into injured tissue and adjacent tissue.

Scleroderma: A chronic connective and autoimmune rheumatic tissue disease that involves the tightening and hardening of the skin and connective tissues. Scleroderma is also referred to as systemic sclerosis and crest syndrome.

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Investigational and Not Medically Necessary:
For the following procedure codes or when the code describes a procedure or product indicated in the Position Statement section as investigational and not medically necessary.

CPT

 

46999

Unlisted procedure, anus [when specified as perianal injection of autologous adipose-derived regenerative cells, e.g., for fistulizing Crohn’s disease]

55899

Unlisted procedure, male genital system [when specified as intracavernous injection of autologous adipose-derived regenerative cells, e.g., for erectile dysfunction]

0489T

Autologous adipose-derived regenerative cell therapy for scleroderma in the hands; adipose tissue harvesting, isolation and preparation of harvested cells including incubation with cell dissociation enzymes, removal of non-viable cells and debris, determination of concentration and dilution of regenerative cells

0490T

Autologous adipose-derived regenerative cell therapy for scleroderma in the hands; multiple injections in one or both hands

0565T

Autologous cellular implant derived from adipose tissue for the treatment of osteoarthritis of the knees; tissue harvesting and cellular implant creation

0566T

Autologous cellular implant derived from adipose tissue for the treatment of osteoarthritis of the knees; injection of cellular implant into knee joint including ultrasound guidance, unilateral

0717T

Autologous adipose-derived regenerative cell (ADRC) therapy for partial thickness rotator cuff tear; adipose tissue harvesting, isolation and preparation of harvested cells, including incubation with cell dissociation enzymes, filtration, washing and concentration of ADRCs

0718T

Autologous adipose-derived regenerative cell (ADRC) therapy for partial thickness rotator cuff tear; injection into supraspinatus tendon including ultrasound guidance, unilateral

 

 

ICD-10 Diagnosis

 

 

All diagnoses

References

Peer Reviewed Publications:

  1. Alentorn-Geli E, Seijas R, Martínez-De la Torre A, et al. Effects of autologous adipose-derived regenerative stem cells administered at the time of anterior cruciate ligament reconstruction on knee function and graft healing. J Orthop Surg (Hong Kong). 2019; 27(3):2309499019867580.
  2. Daumas A, Magalon J, Jouve E, et al. Long-term follow-up after autologous adipose-derived stromal vascular fraction injection into fingers in systemic sclerosis patients. Curr Res Trans Med. 2017; 65(1):40-43.
  3. Daumas A, Magalon J, Jouve E, Casanova D, et al. Adipose tissue-derived stromal vascular fraction for treating hands of patients with systemic sclerosis: a multicentre randomized trial Autologous AD-SVF versus placebo in systemic sclerosis. Rheumatology (Oxford). 2022; 61(5):1936-1947.
  4. Fujita M, Matsumoto T, Sobajima S, Tsubosaka M, et al. Clinical and radiological comparison of single and double intra-articular injection of adipose-derived stromal vascular fraction for knee osteoarthritis. Cell Transplant. 2023; 32:9636897231190175.
  5. Gotoh M, Yamamoto T, Shimizu S, et al. Treatment of male stress urinary incontinence using autologous adipose-derived regenerative cells: long-term efficacy and safety. Int J Urol. 2019; 26(3):400-405.
  6. Granel B, Daumas A, Jouve E, et al. Safety, tolerability and potential efficacy of injection of autologous adipose-derived stromal vascular fraction in the fingers of patients with systemic sclerosis: an open-label phase I trial. Ann Rheum Dis. Dec 2015; 74(12):2175-2182.
  7. Guillaumes S, Hidalgo NJ, Bachero I, et al. Efficacy of injection of autologous adipose tissue in the treatment of patients with complex and recurrent fistula-in-ano of cryptoglandular origin. Tech Coloproctol. 2024; 28(1):81.
  8. Haahr MK, Harken Jensen C, Toyserkani NM, et al. A 12-month follow-up after a single intracavernous injection of autologous adipose-derived regenerative cells in patients with erectile dysfunction following radical prostatectomy: an open-label phase I clinical trial. Urology. 2018; 121:203.e6-203.e13.
  9. Hogaboom N, Malanga G, Cherian C, Dyson-Hudson T. A pilot study to evaluate micro-fragmented adipose tissue injection under ultrasound guidance for the treatment of refractory rotator cuff disease in wheelchair users with spinal cord injury. J Spinal Cord Med. 2021; 44(6):886-895.
  10. Hurd JL, Facile TR, Weiss J, et al. Safety and efficacy of treating symptomatic, partial-thickness rotator cuff tears with fresh, uncultured, unmodified, autologous adipose-derived regenerative cells (UA-ADRCs) isolated at the point of care: a prospective, randomized, controlled first-in-human pilot study. J Orthop Surg Res. 2020; 15(1):122.
  11. Iglesias M, Torre-Villalvazo I, Butron-Gandarillas P, et al. Adipose derived stromal vascular fraction and fat graft for treating the hands of patients with systemic sclerosis. A randomized clinical trial. PLoS One. 2023; 18(8):e0289594.
  12. Jørgensen MG, Toyserkani NM, Jensen CH, et al. Adipose-derived regenerative cells and lipotransfer in alleviating breast cancer-related lymphedema: An open-label phase I trial with 4 years of follow-up. Stem Cells Transl Med. 2021; 10(6):844-854.
  13. Khanna D, Caldron P, Martin RW, et al. Adipose-derived regenerative cell transplantation for the treatment of hand dysfunction in systemic sclerosis: a randomized clinical trial. Arthritis Rheumatol. 2022; 74(8):1399-1408.
  14. Laureti S, Gionchetti P, Cappelli A, et al. Refractory complex Crohn’s perianal fistulas: a role for autologous microfragmented adipose tissue injection. Inflamm Bowel Dis. 2020; 26(2):321-330.
  15. Mattei A, Bertrand B, Jouve E, et al. Feasibility of first injection of autologous adipose tissue-derived stromal vascular fraction in human scarred vocal folds: a nonrandomized controlled trial. JAMA Otolaryngol Head Neck Surg. 2020; 146(4):355-363.
  16. Naldini G, Sturiale A, Fabiani B, et al. Micro-fragmented adipose tissue injection for the treatment of complex anal fistula: a pilot study accessing safety and feasibility. Tech Coloproctol. 2018; 22(2):107-113.
  17. Panchal J, Malanga G1, Sheinkop M. Safety and efficacy of percutaneous injection of Lipogems micro-fractured adipose tissue for osteoarthritic knees. Am J Orthop (Belle Mead NJ). 2018; 47(11).
  18. Sembronio S, Tel A, Tremolada C, et al. Temporomandibular joint arthrocentesis and microfragmented adipose tissue injection for the treatment of internal derangement and osteoarthritis: a randomized clinical trial. J Oral Maxillofac Surg. 2021; 79(7):1447-1456.
  19. Tabit CJ, Slack GC, Fan K, et al. Fat grafting versus adipose-derived stem cell therapy: distinguishing indications, techniques, and outcomes. Aesthetic Plast Surg. 2012; 36(3):704-713.
  20. Ulivi M, Meroni V, Viganò M, et al. Micro-fragmented adipose tissue (mFAT) associated with arthroscopic debridement provides functional improvement in knee osteoarthritis: a randomized controlled trial. Knee Surg Sports Traumatol Arthrosc. 2023; 31(8):3079-3090.
  21. Vieira MHC, de Carvalho Schweich-Adami L, Oliveira RJ, Antoniolli-Silva ACMB. Effect of cell therapy with adipose-derived stem cells in the treatment of acute rupture of the Achilles tendon in humans. Cell Tissue Bank. 2024; 25(3):831-838.
  22. Wang C, Long X, Si L, et al. A pilot study on ex vivo expanded autologous adipose-derived stem cells of improving fat retention in localized scleroderma patients. Stem Cells Transl Med. 2021; 10(8):1148-1156.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. U. S. Food and Drug Administration. Lipogems System. K161636. November 4, 2016. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf16/K161636.pdf. Accessed on November 11, 2024.
  2. U. S. Food and Drug Administration. Regenerative medicine advanced therapy designation. July 21, 2024. Available at: https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/regenerative-medicine-advanced-therapy-designation. Accessed on November 112, 2024.
Websites for Additional Information
  1. National Institutes of Health. National Institute of Arthritis and Musculoskeletal and Skin Diseases. Scleroderma Basics. Last Reviewed: September 2023. Available at: https://www.niams.nih.gov/health-topics/scleroderma/basics/symptoms-causes. Accessed on November 11, 2024.
Index

Autologous adipose-derived regenerative cell therapy
Lipogems
Scleroderma

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Document History

Status

Date

Action

Revised

11/14/2024

Medical Policy & Technology Assessment Committee (MPTAC) review. Revised title and scope of document to address autologous adipose-derived regenerative cell therapy. Moved content related to autologous fat grafting and injectable soft tissue fillers to new document CG-SURG-123. Revised Description/Scope, Position Statement, Rationale, Background/Overview, Definitions, References, Websites for Additional Information, and Index sections. Revised Coding section; removed codes 15771, 15772, 15773, 15774, 11950-11954, 17999, 31574, C1878, G0429, L8607, L8699, Q2026, Q2028 now addressed in CG-SURG-123.

Reviewed

05/09/2024

MPTAC review. Updated the Rationale, Background/Overview, References and Websites for Additional Information sections.

Revised

05/11/2023

MPTAC review. Revised formatting and hierarchy of Position Statement section. Revised cosmetic and NMN statements. Updated the Description/Scope, Background/Overview and References sections.

Reviewed

05/12/2022

MPTAC review. Updated the Rationale, Background/Overview, References and Index sections. Updated Coding section with 07/01/2022 CPT changes, added 0717T, 0718T.

Revised

05/13/2021

MPTAC review. Removed the word “physical” from the term “physical functional impairment” throughout the document. In the reconstructive position statement for autologous fat grafting, added the phrase “(for example, for breast contouring following breast reconstruction procedures)”. Updated the Rationale, Background/Overview, Definitions and References sections.

 

04/07/2021

In Description section, added more prominent note referring reader to SURG.00023. Revised medically necessary definition text in the Description section. Updated Coding section, added L8699 NOC replacing J3490 NOC.

New

05/14/2020

MPTAC review. Initial document development. Information on dermal fillers, collagen injections and hyaluronic acid gel products removed from ANC.0007 Cosmetic and Reconstructive Services: Skin Related and now addressed in this document. Includes medically necessary criteria for injectable soft tissue fillers. Information on adipose-derived regenerative cell therapy removed from MED.00110 Silver-based Products and Autologous Skin-, Blood- or Bone Marrow-derived Products for Wound and Soft Tissue Applications and now addressed in this document.

 

 

 


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