Medical Policies - Surgery


Regenerative Adipose-Cell Therapy for Scleroderma of the Hands

Number:SUR703.055

Effective Date:10-15-2018

Coverage:

*CAREFULLY CHECK STATE REGULATIONS AND/OR THE MEMBER CONTRACT*

Regenerative adipose-cell therapy is considered experimental, investigational and/or unproven for the treatment of scleroderma of the fingers or hands.

Description:

Scleroderma is a chronic connective tissue disease generally classified as one of the autoimmune rheumatic diseases. The seriousness of scleroderma is dependent on the area(s) of the body that are affected.

Background

It is estimated that 300,000 Americans have been diagnosed with scleroderma, and a third of those diagnosed have systemic scleroderma. About 50% of patients have a slower and more benign illness called limited scleroderma. In limited scleroderma, skin thickening is less widespread, typically confined to the fingers, hands and face, and develops slowly over years. There is no known cure.

Limited scleroderma is often called CREST syndrome, which stands for the 5 common features:

Calcinosis – The deposition of calcium in the skin, subcutaneous tissue, muscles and visceral organs;

Raynaud’s phenomenon (RP) – RP is a rare disorder of the blood vessels, usually in the fingers and toes, causing the blood vessels to narrow when cold or stressed;

Esophageal dysfunction – In scleroderma, the valve located at the beginning of stomach does not close properly, resulting in a backwash of acid and a burning sensation (heartburn) as food and acid return into the esophagus;

Sclerodactyly – The localized thickening and tightness of the skin of the fingers or toes, possibly leading to ulceration of the skin of the distal digits, and commonly accompanied by atrophy of the underlying soft tissues; and

Telangiectasia – Dilated superficial blood vessels, which may be seen in rosacea or certain systemic diseases, and may appear as red dots or lines.

Conventional Treatments

Treatment for limited scleroderma focuses on relieving symptoms and preventing complications, using medications, therapy, and/or surgery.

Medications

Several types of medications are used to treat the signs and symptoms of limited scleroderma, including:

Topical antibiotics: for skin ulcers that become infected, followed by oral or intravenous antibiotics as required;

Antacid drugs: for heartburn;

Hypertensive drugs (calcium channel blockers), prostacyclin, or endothelin receptor antagonists: to open small blood vessels and increase circulation might help relieve RP's symptoms; or

Immune suppressant drugs: used to prevent excess collagen that collects in the tissue.

Therapy

Physical or occupational therapy can teach exercises to maintain flexibility and strength in stiff, painful joints.

Surgery

Surgery might be necessary for certain problems, such as:

Removal of calcium deposits that are large or painful; or

Reduction of red spots or lines caused by swollen blood vessels near the surface of the skin.

Autologous Adipose-Derived Regenerative Cell (ADRC) Therapy

Repair and regeneration of human tissue requires a complex combination of regenerative cells from throughout the body. Autologous ADRC therapy has been introduced as a modality to address scleroderma-related hand dysfunction. ADRCs are a mixed population of cells, including adult stem-cells, endothelial progenitor-cells, leukocytes, endothelial cells, and vascular smooth muscle cells. New scientific evidence reveals that ADRCs counteract inflammation, stimulate new blood vessel formation, prevent cell death, and secrete substances needed for repair and regeneration, all to reduce hand dysfunction.

The ADRC infusion procedure consists of 3 phases: 1) liposuction to collect approximately 1-2 cups of adipose tissue (fat) from areas of the body; 2) preparation of the ADRCs; and, 3) injection of the ADRCs into the fingers. The cell preparation and administration uses the Celution® or Habeo™ Cell Therapy Systems, which Cytori Therapeutics, Inc. calls their Cytori Cell Therapy™ (ECCS-50). They have reported this therapy as a novel approach that has the potential to harness the power of a patient’s own cells to promote healing. The entire procedure from the start of the liposuction through to completion of the finger or hand injections will take approximately 6 hours, as an outpatient. Cytori Therapeutics, Inc., encourages follow-up visits occurring at regular intervals, which is currently part of Cytori’s clinical trial protocol listed within their product information. (1)

Regulatory Status

The Celution® System and Habeo™ Cell Therapy were developed by Cytori Therapeutics, Inc. (San Diego, CA), to repair injured tissue, preserve function, improve quality of life, and modify disease progression. The Habeo™ Cell Therapy is being specially developed and tested for treatment of scleroderma of the hand.

A point-of-care system is available for concentrating ADSC from mature fat. The Celution™ System is designed to transfer a patient’s own adipose tissue from 1 part of the body to another in the same surgical procedure. (2) In September 2006, Celution™ Cell Concentration System (Cytori Therapeutics, Inc.) was cleared for marketing by the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) through the 510(k) process as a cell saver device. The system is cleared for the collection, concentration, washing, and reinfusion of a patient’s own cells for applications that may include, but are not limited to, cardiovascular, plastic and reconstructive, orthopedic, vascular, and urological surgeries and procedures. FDA product code: CAC.

As of November 30, 2017, the Habeo™ Cell Therapy System has not received FDA CDRH premarket approval (PMA) or 510(k) processes. Cytori Therapeutics, Inc., has applied to the FDA for future review of this system.

Rationale:

This medical policy was developed based on a MedLine search of peer-reviewed scientific literature and a review of clinical trials completed through November 2017. The following is a summary of the key literature to date.

The results of 12 patients participating in the French Phase I open-label trial, SCLERADEC-1 were published in 2015 by Granel et al. (3) The study goal was to measure the safety, tolerability and potential efficacy of autologous adipose tissue-derived stromal vascular fraction (SVF) locally injected into the hands of patients with scleroderma. The 12 female patients in the single-arm study were followed for 6 months. Four minor adverse events were reported and resolved spontaneously. A significant improvement in hand disability and pain, Raynaud's phenomenon (RP), finger edema and quality of life was observed. The research group concluded

potential efficacy needs confirmation in a randomized placebo-controlled trial on a larger population.

Longer follow-up observations were completed for the same 12 patients discussed above. In 2017, Daumas et al. published the results at 22 and 30 months after initial treatment. (4) Multiple patient-reported outcomes showed sustained improvement, in comparison with the assessment performed just before surgery: 62.5% in the Cochin Hand Function Scale, 51.1% in the Scleroderma Health Assessment Questionnaire, 33.1% in hand pain, and 88.3% in the Raynaud Condition Score. A decrease in the number of digital ulcers number was noted. Mobility, strength and fibrosis of the hand also showed improvement. None of the 8 patients who had previously received Iloprost infusion required new infusion. Iloprost is a drug used to treat pulmonary arterial hypertension (PAH), scleroderma, RP and other diseases in which the blood vessels are constricted and blood can't flow to the tissues. The authors recommended review of the results of the 2 ongoing studies before final determination of “the place of this innovative therapy” for scleroderma patients.

Cytori Therapeutics, Inc., is currently investigating the Habeo™ Cell Therapy in patients with hand dysfunction because of scleroderma. This is a U.S. Phase III randomized, double-blind, placebo controlled, parallel-group, multi-center study, known as the STAR study (NCT02396238). (1) Preliminary results have not been published.

Ongoing and Unpublished Clinical Trials

Some currently ongoing trials that might influence this review are listed in Table 1.

Table 1. Summary of Key Trials

NCT No.

Trial Name

Planned Enrollment

Completion Date

Ongoing

NCT02396238a

Scleroderma Treatment with Celution Processed Adipose-derived Regenerative Cells (STAR)

88

Dec 2018

NCT03060551

Injection of Autologous Adipose-derived Stromal Vascular Fraction in the Finger of Systemic Sclerosis Patients

50

Jan 2018

Table Key:

NCT: National Clinical Trial;

No: number;

a: Industry-sponsored clinical trial.

Professional Guidelines and Position Statements

There are no professional guidelines and position statements that would support the use of regenerative adipose-cell therapy for the treatment of scleroderma of the fingers and hands.

Summary of Evidence

The available evidence published in the peer-reviewed literature is inadequate to conclude outside of clinical trials, the safety, efficacy, and utilization of autologous adipose-derived regenerative cell (ADRC) therapy to treat scleroderma of the fingers and hands. Larger, randomized comparative studies are needed to assess health outcomes using this therapy. Therefore, regenerative adipose-cell therapy is considered experimental, investigational and/or unproven for the treatment of scleroderma of the fingers or hands.

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

CODING:

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

0489T, 0490T

HCPCS Codes

None

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does not have a national Medicare coverage position. Coverage may be subject to local carrier discretion.

A national coverage position for Medicare may have been developed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.

References:

1. Celution™ System and Habeo™ Cell Therapy – Product information. Cytori Therapeutics., Inc., San Diego, CA. Available at: <http://www.cytori.com> (accessed on November 30, 2017).

2. FDA – Cytori Celution Cell Concentration Device Product Classification 510(k) Summary (September 28, 2006). U.S. Food and Drug Administration, Center for Devices and Radiological Health. Available at: <http://www.fda.gov> (accessed on November 30, 2017).

3. 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):2175-82. PMID 25114060

4. 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. Jan-Mar 2017; 65(1):40-3. PMID 28340695

Policy History:

DateReason
10/15/2018 Reviewed. No changes.
1/1/2018 New medical document. Regenerative adipose-cell therapy is considered experimental, investigational and/or unproven for scleroderma of the fingers or hands.

Archived Document(s):

Title:Effective Date:End Date:
Regenerative Adipose-Cell Therapy for Scleroderma of the Hands01-01-201810-14-2018
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