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Trial Evaluating the Efficacy of Systemic Mesenchymal Stromal Cell (MSC) Injections for the Treatment of Severe and Chronic Radiotherapy-induced Abdomino-pelvic Complications (Pelvic Radiation Disease, PRD) Refractory to Standard Therapy (PRISME)

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ClinicalTrials.gov Identifier: NCT02814864
Recruitment Status : Not yet recruiting
First Posted : June 28, 2016
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

Patients receiving radiation therapy are still at risk for side effects due to off-target radiation damage of normal tissues The number of cancer patients is expected to increase from 14.1 million around the world in 2012 to 19.3 million in 2025. Up to ten percent will develop late severe gastrointestinal complications (i.e. Pelvic Radiation Disease - PRD). Symptoms are proctopathy (5-20%) and radiation-induced cystitis (3,5%) that affect quality of life. The treatment of PRD is limited to managing the symptoms; new alternatives should be proposed.

Clinical trials using MSCs to treat hemorrhagic cystitis, proctopathy have demonstrated the feasibility to used MSCs in these pathologies :

  • MSCs successfully repair hemorrhagic cystitis, and perforated colon in patients with hemorrhagic cystitis, perforated colon and peritonitis.
  • Six clinical trials are currently ongoing for proctopathy, 3 are phase III. Results suggest an inhibition of chronic inflammation and fistulization and interruption of hemorrhagic syndromes.
  • Clinical trials to evaluate the efficacy of MSCs to treat hemorrhagic cystitis is in progress.
  • A decrease in pain after the injection of MSCs was observed in patients treated by radiotherapy for breast cancer, radiation burns, and radiotherapy over-dosage.
  • Four patients, were treated with MSCs after receiving overdose pelvic irradiation for prostate cancer. A decrease in pain (EN score), bleeding and diarrhea was observed.

MSCs will represent a promising alternative strategy in the treatment of severe enteritis, rectitis and cystitis after radiotherapy, and may avoid surgical treatment and may diminish the adverse effect of PRD in terms of chronicity, morbidity, mortality and health costs.


Condition or disease Intervention/treatment Phase
Pelvic Radiation Therapy Radiation-induced Hemorrhagic Cystitis Drug: Mesenchymal Stromal Cell (MSC) injections Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Phase II Trial Evaluating the Efficacy of Systemic Mesenchymal Stromal Cell (MSC) Injections for the Treatment of Severe and Chronic Radiotherapy-induced Abdomino-pelvic Complications (Pelvic Radiation Disease, PRD) Refractory to Standard Therapy
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : January 2021

Arm Intervention/treatment
Experimental: Mesenchymal Stromal Cell (MSC)
Patient with chronic radiotherapy-induced abdomino-pelvic complications refractory to standard therapy: 12 patients suffering of PRD (LENT-SOMA scale>2)
Drug: Mesenchymal Stromal Cell (MSC) injections
12 patients suffering of PRD (LENT-SOMA scale>2) will receive Mesenchymal Stromal Cell (MSC) injections
Other Name: Cell therapy




Primary Outcome Measures :
  1. Decrease of one grade on the LENT SOMA [ Time Frame: 4 months after the first injection of MSCs ]
    Decrease of one grade for rectorrhagia or hematuria on the LENT SOMA scale (Late Effects Normal Tissue Task Force -Subjective, Objective, Management, Analytic), 4 months after the first injection of MSCs.


Secondary Outcome Measures :
  1. The effect of treatment on analgesic drug consumption (analgesic, opiates). [ Time Frame: 4 months after the first injection of MSCs ]
    Frequency of drug consumption (analgesic, opiate)

  2. The effect of treatment on quality of life with SF36 questionnaire [ Time Frame: 4 months after the first injection of MSCs ]
    Quality of life evaluated by SF36 questionnaire (short form survey)

  3. The effect of treatment on quality of life with HADS questionnaire [ Time Frame: 4 months after the first injection of MSCs ]
    Quality of life evaluated by questionnaire Hospital Anxiety and Depression Scale (HADS)

  4. The effect of treatment on pain [ Time Frame: 4 months after the first injection of MSCs ]
    Mean pain intensity evaluated by Visual Analogue Scale (VAS) during the week prior to the visit.

  5. Frequency of diarrhea [ Time Frame: 4 months after the first injection of MSCs ]
    diminution of the frequency of diarrhea



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age ≥18 years and <80 years;
  • Any pelvic cancerous pathology irradiated with a history of pelvic complications of grade > 2 LENT SOMA scale);
  • Absence of metastasis objectified by bone scintigraphy;
  • After failure following at least three lines of conventional treatment;
  • Good physical condition (WHO-performance status 0-1)

Exclusion Criteria:

  • Pregnancies (Pregnancy test carried out during the inclusion examination).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02814864


Contacts
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Contact: Mohamad MOHTY, PhD 01 49 28 26 20 ext +33 mohamad.mohty@inserm.fr
Contact: Alain CHAPEL, PhD 0158359546 ext -33 alain.chapel@irsn.fr

Locations
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France
Hématologie et thérapie cellulaire, Hôpital Saint Antoine Not yet recruiting
Paris, France, 75012
Contact: Mohamad MOHTY, PhD    01 49 28 26 20 ext +33    mohamad.mohty@inserm.fr   
Contact: Alain CHAPEL, PhD    0158359546 ext +33    alain.chapel@irsn.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Mohamad MOHTY, PhD mohamad.mohty@inserm.fr

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02814864     History of Changes
Other Study ID Numbers: P130935
2014-001462-99 ( EudraCT Number )
First Posted: June 28, 2016    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Hematology
Mesenchymal Stromal Cell
radiotherapy
gastro-intestinal complications
lower digestive tract cancers
colitis
bleeding
diarrhea
pelvic radiation disease

Additional relevant MeSH terms:
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Cystitis
Urinary Bladder Diseases
Urologic Diseases