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 : Recruiting
First Posted : June 28, 2016
Last Update Posted : May 29, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||April 18, 2019|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||April 2021|
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
- 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.
- 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)
- 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)
- 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)
- 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.
- Frequency of diarrhea [ Time Frame: 4 months after the first injection of MSCs ]diminution of the frequency of diarrhea
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
|Contact: Mohamad MOHTY, PhD||01 49 28 26 20 ext +firstname.lastname@example.org|
|Contact: Alain CHAPEL, PhD||0158359546 ext -email@example.com|
|Principal Investigator:||Mohamad MOHTY, PhDfirstname.lastname@example.org|